30 Regulatory Affairs jobs in the United Arab Emirates

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

• Responsible for the overall compilation of regulatory submissions to the Health Authorities, drafting Product Information, Clinical Information, literature searches to support submissions, product analysis, changes in manufacturing, pack sizes, CPI and PIL development, packaging changes, notification and other regulatory activities.
• Prepare and submit the Registration dossiers for the health authorities in different countries as per their current guidelines.
• Respond to the queries received from the health authorities. 4. Review of outsourced registration dossier
• Review of open part API drug master file (APIDMF)
• Coordinate with the regulatory agents in countries, distributors, and other departments concerned with fulfilling the registration requirements.
• Update the product-specific APQR sheet, which comprises complete approved information related to the product at the time of approval in the related market.
• Ensure that all state and International regulatory requirements are addressed for the marketed products and New Product submission.
• Monitor proactively relevant governmental bodies to identify changes in legislation/regulations.
• Maintains knowledge of the current regulatory guidelines environment by reviewing and communicating current decrees policies/practices issued by Health Ministry.
• Maintain up-to-date documentation within the regulatory database
  

Role: Regulatory Affairs Manager
Location: Abu Dhabi
Role Purpose:
The Regulatory Affairs & FATCA/CRS Manager is the primary Point of Contact (PoC) / Designated FATCA CRS Officer for ADIB Group, who will maintain ADIB’s regulatory relationships with competent regulators including Central Bank of UAE (CBUAE) and Securities and Commodities Authority (SCA) and UAE Ministry of Finance and ensure that ADIB has in place a robust framework to meet its regulatory commitments in line with global standards for the automatic exchange of financial account information. Key accountabilities of the role include:

• Develop and maintain internal procedures, standards, self-certification processes and guidance checklists to Businesses and Group Entities in line with UAE Ministry of Finance, Central Bank of UAE and Competent Tax Authorities for compliance with FATCA & CRS policies and governance documents.
• Act as the subject matter expert (SME) in respect of FATCA & CRS for the function, businesses and support functions.
• Submit accurate and timely reporting to the various Competent Tax Authorities.
• Develop Data Validation processes to ensure completeness and accuracy of information received.
• Provide inputs to bank’s data governance framework to prescribe all required data to be captured and maintained within core banking systems from onboarding channels.
• Assess and propose enhancements and implement changes to procedures and internal systems for improved automation and end-to-end workflow and controls.
• Maintain relationships with Data Governance, Technology and Client On-boarding teams as required, for effective troubleshooting and successful end-to-end workflows.
• Provide support with Group Internal Audit requests, ensuring accurate information is provided in a timely manner.
• Provide Training guidance and advice on entity classifications and reportable information each financial year.
• Support the implementation and configuration of Reporting Tools and leveraging of AI.

Key Accountabilities of the role:

Policies and Procedures:

• Support in maintenance and update of Regulatory Affairs and Ethical Conduct related policies, procedures, and processes.
• Ensure the continuous monitoring and update of Regulatory Affairs Related policies by addressing regular updates to Head of Regulatory Affairs on their renewal status and market/regulatory evolution.

FATCA and CRS:

• Ensure the continuous review, enhancement and oversight of FATCA and CRS regulations, policies and procedures.
• Investigate, advise and challenge the onboarding documentation process and assessment of FATCA/CRS compliance risks associated to ADIB.
• Coordinate and finalize any ad-hoc gap assessment of the FATCA and CRS policies and procedures against updated regulatory requirements and ensure oversight or implementation throughout ADIB.
• Ensure continuous maintenance of training material (including role-based training) and upskilling on FATCA and CRS requirements and obligations to relevant staff across ADIB.
• Continuously support the review of Business Units systems to ensure the sound capture of FATCA/CRS indicia.
• Ensure the data accuracy and timely submission of the FATCA and CRS reporting expected by CBUAE and SCA on a yearly basis through their respective portal.
• Provide complete, accurate, practical and timely advice, opinion or documentation for regulatory ad-hoc enquiries raised by the regulatory authorities.
• Provide regulatory advisory on FATCA and CRS inquiries raised by Business Units/Branches system requirements and FATCA/CRS reporting.
• Ensure continuous update of FATCA and CRS mandate to all units of business (Retail Individual, Business banking, WBG, Financial institutions) in line with the applicable regulation.
• Participate in system enhancements regarding any regulatory update pertaining to implementation of FATCA and CRS.

Data Validation and Reporting:

• Support in the preparation of MIS reports for internal regulatory affairs reporting, including Management Committees.
• Support the preparation and maintenance of ADIB regulatory returns/reporting register and monitor adherence to defined due dates.
• Ensure the continuous validation of the Regulatory Reporting suite applicable to Regulatory Affairs and support their template design if not provided by regulatory authorities.
• Ensure reporting of material non-compliances/breaches in line with the prevailing policies in a timely manner.

Staff Ethical Behavior:

• Demonstrate strong adherence to ADIB Conduct Risk Pillars and Code of Ethics in terms of transparency, integrity, confidentiality, respect and collaborative workplace.
• Demonstrate strong adherence to ADIB ethical conduct framework in reporting any conflict of interest event or any witnessed behavior which breaches code of ethics to Human Resources.
• Ensure to participate in the transparency and trust culture within the bank by reporting in good faith any concerns, misconduct or malpractice through the Whistleblowing framework.

Specialist Skills / Technical Knowledge Required for this role:

• Advanced Degree in Finance, Business, or any related subject.
• 5+ years of experience with International Reporting, including Taxation and specialist knowledge of FATCA/CRS regulations reporting and operationalization.
• Ability to be independent and perform innovative thinking to solve complex problems with no established precedence while balancing risk, speed, and accuracy.
• Exemplary knowledge of the UAE regulatory environment, regulatory structures, market practice and industry groups.
• Good communication skills and ability to interact with various stakeholders throughout the bank. Ability to quickly acquire knowledge of new regulations, rules and their impact on business. Ability to adopt a problem-solving approach and autonomous work on dedicated tasks.
• Strong interpersonal skills with the ability to communicate with impact, build healthy professional connections, influence outcomes, and simplify complex topics into actionable recommendations for decision-making.

• Job Identification: 2478
• Posting Date: 11/12/2024, 06:37 AM
• Apply Before: 12/12/2024, 06:36 AM
• Locations: Abu Dhabi, Al Rowdah, Shk Rashid Bin Saeed St. 313 ADIB New Headquarters Branch, Sh. Zayed Main Branch Abu Dhabi United Arab Emirates, Abu Dhabi, AE

Job Description

We are NTS Group.

The regions leading Executive Search Outplacement & Career Transition firm across the Middle East bringing over 25 years of local expertise and a track record of exceptional service for our clients and candidates. Operating from our strategically positioned offices in Dubai London and Singapore we offer a comprehensive range of services delivered by industry experts. These include Contingency & Executive Search Campaigns Outplacement & Redundancy Support RPO Projects Talent Mapping Women in Leadership & Leadership Development and our awardwinning Executive Career Transitioning Programs.

We are currently working with a leading global Healthcare company to recruit aRegulatory Affairs Manager based in the UAE. This position will be responsible for overseeing the regulatory affairs function ensuring compliance with local and international regulations and supporting the companys strategic business objectives.

What Youll be Doing

• Leading the regulatory affairs team to ensure effective management of product registrations variations renewals and compliance processes.
• Developing and executing regulatory strategies to support new product launches market access and lifecycle management of the portfolio.
• Acting as the primary point of contact with UAE health authorities such as the Ministry of Health to manage regulatory submissions and resolve queries.
• Monitoring interpreting and implementing changes in local and international regulations ensuring the business remains compliant and informed.
• Collaborating with crossfunctional teams including R&D marketing supply chain and legal to align regulatory processes with business goals.
• Overseeing the preparation review and submission of regulatory dossiers and related documentation.
• Establishing and maintaining robust systems for regulatory documentation reporting and compliance tracking.
• Providing regulatory advice and training to internal stakeholders to enhance organizational awareness and compliance standards.

Who You Are

• Bachelors degree in Pharmacy Life Sciences or a related field (Masters degree is preferred).
• 6 years of experience in Regulatory Affairs within the healthcare industry including at least 2 years in a managerial or leadership role.
• Comprehensive knowledge of UAE and GCC regulatory guidelines as well as international standards (e.g. ICH WHO).
• Proven experience in managing regulatory submissions approvals and compliance frameworks.
• Strong leadership and team management skills with the ability to mentor and develop talent.
• Excellent communication and interpersonal skills capable of building strong relationships with health authorities and internal stakeholders.
• High attention to detail organizational skills and the ability to manage complex projects and multiple priorities.
• Proficiency in Microsoft Office and regulatory management systems.

Due to the large number of applications we receive we can only respond to candidates who have been shortlisted for the position. If you havent had a response within 5 working days please assume you have not been shortlisted. Many thanks and good luck in your job search.

Required Experience:

Manager

Direct message the job poster from KIKO MILANO

KIKO Milano is a leading cosmetics company seeking a highly motivated individual to join our Regulatory Middle East, India, and Africa team. As a Senior Regulatory Affairs Coordinator, you will support the Regulatory Affairs department in registration, tracking updates, communication, and compliance. The ideal candidate will have proven experience and extensive knowledge of Regulatory Affairs schemes and Cosmetics regulations, specifically in the Middle East, along with excellent interpersonal skills.

This is a great opportunity for a highly organized and detail-oriented person to join our dynamic and growing team.

KIKO Milano is committed to enabling everyone to enjoy innovative, high-quality cosmetics without sacrificing their budget. We aim to provide top-quality shades, packaging, and formulas that are always on trend, allowing customers to experiment confidently with makeup and treatments.

Our goal is to redefine beauty care by making quality accessible at every price point. With KIKO, professional luxury becomes an exciting, tangible reality for all budgets.

Role: Senior Regulatory Affairs Coordinator

Reports to: Regulatory Affairs Coordinator

Location: Dubai, UAE

• Investigate, contact relevant authorities, confirm, and report information regarding cosmetics regulations and registrations.
• Monitor changes in cosmetic legislation and registration requirements, conduct risk assessments, and communicate action plans and impacts promptly.
• Ensure product compliance (formula, labeling, and claims) with local regulations and manage submissions for regulatory approval.
• Maintain a detailed tracker of registration statuses and validity.
• Lead decision-making, providing recommendations and solutions within the regulatory framework.
• Support regional and headquarters teams on regulatory and registration tasks.
• Minimum of 2 years of related experience in Regulatory Affairs or Cosmetics regulations in the Middle East.
• Academic degree in Chemistry, Biology, Chemical, or Biochemical fields.
• Fluency in Arabic and English, both written and spoken.

• Associate

• Full-time

• Legal, Quality Assurance, and Research

• Consumer Services, Pharmaceutical Manufacturing, Retail

Referrals increase your chances of interviewing at KIKO MILANO by 2x.

• Gulf Regulatory Affairs Associate, Dubai (m/f/*)
• Assistant Manager - Regulatory Enablement and Legal
• Assistant Manager - Enterprise and Regulatory Risk (UAE Only)

Gulf Regulatory Affairs Associate, Dubai is a crucial role that requires strong skills and knowledge in regulatory affairs.

This job involves managing product stewardship and customer interaction in the Gulf region, obtaining and managing local external certifications, and contributing to regulatory activities associated with new and existing products.

The ideal candidate will have excellent communication, narrative development, and organizational abilities, as well as experience in managing customers and hosting visitors.

Key responsibilities include leading product registration, managing certifications, and ensuring timely renewals, while also overseeing and promoting 3M Customer Innovation Center in Dubai.

The successful candidate will be a UAE National ID holder, fluent in Arabic and English, with flexibility on working hours around customer visits to CIC as per customers' request.

The company seeks and values diversity and inclusion, and this Job ad is addressed to all potential candidates, without discrimination against any applicant for employment based on race/ethnicity, nationality, religion, sex, pregnancy/maternity-related matters, age or disability.

This role may include up to 10% domestic/international travel expectations.

Our client is a global multinational looking to recruit a Regulatory Affairs Manager for their operations in Dubai. The person will be responsible for the Middle East region.

This role is responsible for ensuring product compliance with regional health authorities, overseeing submissions, approvals, and post-market surveillance.

• Develop and implement regulatory strategies to support product registration and market access across the Middle East.
• Prepare, submit, and manage regulatory dossiers for new registrations, renewals, and variations.
• Act as the primary liaison with health authorities (MOH, SFDA, DHA, GCC DR, etc.) to ensure timely approvals.
• Ensure labelling, packaging, and promotional materials comply with local regulatory requirements.
• Monitor regulatory changes and provide strategic guidance on their impact on product compliance.

• Ensure adherence to post-market surveillance and reporting obligations.
• Manage adverse event reporting and product recalls in coordination with regional regulatory bodies.
• Maintain up-to-date regulatory documentation and ensure inspection readiness.

• Work closely with R&D, Quality, Commercial, and Supply Chain teams to align regulatory strategies with business goals.
• Provide regulatory input for product development, clinical evaluation, and market expansion plans.
• Conduct internal training sessions on regulatory requirements for relevant teams.

The ideal candidate for the role will:

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
• 5+ years in regulatory affairs within medical technology, medical devices, or health care products.
• Strong communication skills for regulatory interactions.
• Ability to manage multiple country submissions and post-market compliance.

As a Manager Security AVSEC Regulatory Affairs, you will be responsible for the development and management of the Legislative/Regulatory Affairs framework for Aviation and Corporate Security within the Emirates Group, ensuring compliance with government and aviation industry regulations along with the Emirates Aircraft Operator Security Programme (AOSP). Additionally you will, coordinate with government aviation regulatory bodies and develops Supplementary Security Plans for Emirates' destinations to ensure alignment with regulatory requirements and support company goals.

In this role, you will:

• Lead the development of the Emirates Aircraft Operator Security Programme in compliance with UAE regulations. Strategically oversee, develop, and implement network-wide security standards aligned with international laws to safeguard passengers, crew, and operations. Continuously review and update security directives and SOPs, ensuring effective communication with senior leadership and relevant departments.
• Analyse, evaluate and provide recommendations with regards to any contravention of security standards, clauses, measures and controls. Advise on necessary actions to restore security standards following contraventions. Provide advice on the implementation of measures & controls during periods of increased risk or for special flights and routes.
• Develop and maintain strong relationships with aviation authorities, airport officials, and law enforcement to support secure operations. Engage with key regulators like UAE GCAA, US TSA, UK DfT/CAA, EU regulators, CAT, and Australian authorities, stay updated on policies, ensure compliance, and advise management on regulatory standards while collaborating with Emirates Group departments.
• Keep abreast all national, international, and foreign AVSEC legislation and their amendments/enhancements/changes that may affect Emirates operation in and outside the UAE. Develop, maintain and implement an Aviation Security Programme to promote the level of awareness and subsequent acceptance, for UAE operations, with reference to GCAA and other governmental requirements.
• Lead on the development of a Security Management System and document that system, to facilitate the implementation of an effective system of documentation, practices and controls, that will provide the framework for the conduct and management of all security operations in Emirates Group.
• Manage the development of policies and practices to enhance service quality, improve operational efficiency, and ensure compliance with local and international security regulations. Develop policies and procedures for the management of security operations at high threat / vulnerable stations, and for the management of special movements.
• Oversee the proper investigation of any security breaches, incidents or acts of unlawful interference directed at Emirates aircraft, staff, facilities, or property. Ensure proper fact-finding on the details of incidents and assess any mitigating factors; make recommendations for any preventive and corrective security measures/protocols and monitor the implementation and subsequent effectiveness of such measures. Liaise with Appropriate Authorities and agencies when informed of any non-compliances/violations of standards and security protocols.
• Develop and maintain policies, programs, standards, and documentation for audits, inspections, and assessments by external authorities. Ensure compliance with regulations and best practices, including IOSA, ISAGO, ICAO, IATA, GCAA, and other industry standards. Oversee validations, security frameworks, and impact assessments related to regulatory changes, security, and safety culture.
• Work with Hub Operations and Threat and Risk Unit to develop, implement and manage security operations and procedures at the Dubai Hub and Outstations. Provide detailed advice to ensure that all developed procedures comply with regulatory mandates, AOSP, and SeMS.
• Act as the primary liaison with the appropriate authorities to operationalise mandated Security Procedures vis- -vis the categorisation of the airport(s) as normal/high risk with each component of aircraft/flight and ground operations (Green/Amber/Red) from AVSEC and Safety perspective.

About the role:

As a Manager Security AVSEC Regulatory Affairs, you will be responsible for the development and management of the Legislative/Regulatory Affairs framework for Aviation and Corporate Security within the Emirates Group, ensuring compliance with government and aviation industry regulations along with the Emirates Aircraft Operator Security Programme (AOSP). Additionally you will, coordinate with government aviation regulatory bodies and develops Supplementary Security Plans for Emirates' destinations to ensure alignment with regulatory requirements and support company goals.

In this role, you will:

• Lead the development of the Emirates Aircraft Operator Security Programme in compliance with UAE regulations. Strategically oversee, develop, and implement network-wide security standards aligned with international laws to safeguard passengers, crew, and operations. Continuously review and update security directives and SOPs, ensuring effective communication with senior leadership and relevant departments.
• Analyse, evaluate and provide recommendations with regards to any contravention of security standards, clauses, measures and controls. Advise on necessary actions to restore security standards following contraventions. Provide advice on the implementation of measures & controls during periods of increased risk or for special flights and routes.
• Develop and maintain strong relationships with aviation authorities, airport officials, and law enforcement to support secure operations. Engage with key regulators like UAE GCAA, US TSA, UK DfT/CAA, EU regulators, CAT, and Australian authorities, stay updated on policies, ensure compliance, and advise management on regulatory standards while collaborating with Emirates Group departments.
• Keep abreast all national, international, and foreign AVSEC legislation and their amendments/enhancements/changes that may affect Emirates operation in and outside the UAE. Develop, maintain and implement an Aviation Security Programme to promote the level of awareness and subsequent acceptance, for UAE operations, with reference to GCAA and other governmental requirements.
• Lead on the development of a Security Management System and document that system, to facilitate the implementation of an effective system of documentation, practices and controls, that will provide the framework for the conduct and management of all security operations in Emirates Group.
• Manage the development of policies and practices to enhance service quality, improve operational efficiency, and ensure compliance with local and international security regulations. Develop policies and procedures for the management of security operations at high threat / vulnerable stations, and for the management of special movements.
• Oversee the proper investigation of any security breaches, incidents or acts of unlawful interference directed at Emirates aircraft, staff, facilities, or property. Ensure proper fact-finding on the details of incidents and assess any mitigating factors; make recommendations for any preventive and corrective security measures/protocols and monitor the implementation and subsequent effectiveness of such measures. Liaise with Appropriate Authorities and agencies when informed of any non-compliances/violations of standards and security protocols.
• Develop and maintain policies, programs, standards, and documentation for audits, inspections, and assessments by external authorities. Ensure compliance with regulations and best practices, including IOSA, ISAGO, ICAO, IATA, GCAA, and other industry standards. Oversee validations, security frameworks, and impact assessments related to regulatory changes, security, and safety culture.
• Work with Hub Operations and Threat and Risk Unit to develop, implement and manage security operations and procedures at the Dubai Hub and Outstations. Provide detailed advice to ensure that all developed procedures comply with regulatory mandates, AOSP, and SeMS.
• Act as the primary liaison with the appropriate authorities to operationalise mandated Security Procedures vis- -vis the categorisation of the airport(s) as normal/high risk with each component of aircraft/flight and ground operations (Green/Amber/Red) from AVSEC and Safety perspective.

To be considered for this role, you must meet the below requirements:

• Bachelors Degree or Honours (12+3 or equivalent)
• 10+ years experience in Airline, Airport, or Cargo Security.
• Should possess ICAO PMC certification (or equivalent) and/or ICAO National Auditor Certification.
• Must be proficient in interpretation of the Legislations, Regulatory Standards, and Industrial Affairs; together with drafting, developing, and implement security policies and procedures, operating manuals/SOPs and other such documents.
• Knowledge of ICAO, IATA, IOSA, ISAGO, USAP, TSA, ACC3/RA3, Transport Canada, Australia, NZ OTS, UK DfT, EU, SeMS, Doc 8973, Annex 17, 9 and other associated SARPs, AVSEC Conventions plus Protocols.
• Knowledge of International Terrorism and Risk Analysis & Threat Assessment and in its mitigation would be an advantage.
• Good knowledge of technology and systems and the understanding of project management.
• Skilled in problem solving; strong interpersonal, influencing and negotiation skills are required.
• Competent in respect to Quality Control and Assurance and its Management, Risk Analysis and Threat Assessment, Management of Change, Coaching, Communication Processes, Promoting Process Improvement,

Disclaimer: Naukrigulf.com is only a platform to bring jobseekers & employers together. Applicants are advised to research the bonafides of the prospective employer independently. We do NOT endorse any requests for money payments and strictly advice against sharing personal or bank related information. We also recommend you visit Security Advice for more information. If you suspect any fraud or malpractice, email us at

Get AI-powered advice on this job and more exclusive features.

Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research And Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
Summary
Support the Regulatory Affairs department in the preparation, management and maintenance of the technical and regulatory documentation necessary to ensure compliance with the regulatory requirements applicable to the BioMarin products.
Responsabilities

• Support and prepare Health Authority submissions for registered and non-registered products and follow approval process. (MAH/GMP applications, new Marketing Authorization (MA) application, renewal submissions, lifecycle activities etc.)
• Compile all required documents and prepare submission dossiers according to local requirements and make timely applications.
• Conduct the correspondences for all registered/non-registered products and follow up the Health Authority processes.
• Ensure coordination and collaboration with corporate RA Leads to communicate regional strategy for submissions, including potential risks and gating factors, to internal stakeholders located at Headquarters.
• Assist in managing global/local project timelines and planning.
• Ensure the databases are updated on a timely basis.
• Interface with external partners and contractors as needed.
• Perform promotional material review for Middle East & Africa Region.
• Evaluate local regulations/guidance and provide accurate assessments for Middle East & Africa region
  

• Bachelors degree in Pharmacy, Chemistry, Biology
• Minimum 3 – 5 years of Regulatory Affairs experience in a pharmaceutical company,
• Excellent command of English (both written and spoken),
• Strong commitment to compatibility, scientific quality and integrity
• Analytical thinking
• Good communication and teamwork collaboration
• Good detail-capturing skills while working in a fast-moving environment
  

• Seniority levelMid-Senior level

• Employment typeTemporary

• Job functionLegal
• IndustriesBiotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at BioMarin Pharmaceutical Inc. by 2x

Get notified about new Regulatory Affairs Associate jobs in Dubai, Dubai, United Arab Emirates.

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

No visa or accommodation sponsorship

You will be responsible for regulatory activities required at a country level for pharmaceutical products including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval, etc., ensuring regulatory compliance in the applicable market(s).

As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients, global pharmaceutical companies.

JOB OVERVIEW

Essential Functions

• Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries.
• Submit submissions such as renewals, variations, new applications, filings, MAH transfers to the local Health Authority and EMA, and follow up on the local regulatory approval process for designated countries.
• Preparation of local Product Labelling (e.g., SmPC, PIL) in local language for designated countries.
• Artwork review and approval in client systems.
• Manage multiple pharmaceutical products.
• Act as subject matter expert in regulatory processes.
• Acts as a Regulatory Team Leader on more complex projects which may include authoring of regulatory documentation and filling application forms.
• Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned, and discuss customer comments.
• Acts as a Subject Matter Expert in Regulatory knowledge in Chemistry Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing.
• Project budget management.
• Give guidance to junior colleagues including feedback on the quality of technical documents and may assist in their training and development.
• Possible exposure to present to clients on complex regulatory processes and bid defense meetings.
• Act as reviewer for regulatory standard operating procedures.
• Prepare and deliver internal regulatory training if required.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Experience: Typically requires 8-10 years of prior relevant experience.

Education: Masters Degree in Life Sciences or related discipline.

Skills and Abilities:

• Good understanding of the Research and Development process (Chemistry Manufacturing & Controls) relevant regulatory guidelines.
• Possesses specific regulatory or technical expertise.
• Interpersonal communication (oral and written) and organization skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Demonstrates self-motivation and enthusiasm.
• Ability to adapt quickly to a rapidly changing environment.
• Knowledge of Maintenance of Marketing Authorization.
• Experience of preparing variation renewal packages and artwork approvals.
• Fluent in English and able to effectively communicate complex business language to those who speak English as a second language.
• Must be fluent in Arabic.

#LIRemote

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. Learn more at