13 Pharmaceutical Regulations jobs in the United Arab Emirates

Regulatory Affairs Manager

Abu Dhabi, Abu Dhabi Abu Dhabi Islamic Bank PJSC

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Job Description

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 Info
  • 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
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Specialist - Regulatory Affairs

Ras Al Khaimah, Ra's al Khaymah Julphar

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Job Description

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
We value people from different backgrounds. Could this be your story? Apply today or visit to read more about us and the journey of Julphar
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Regulatory Affairs Trainee

Dubai, Dubai SEPHORA

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Job Description

Reporting to: Compliance & Master Data Director

Location: Dubai, United Arab Emirates

At Sephora, beauty is about feeling seen, valued, and empowered, individually and collectively. It is connecting deeply with others, celebrating diversity and inclusivity, unlocking your potential and making a difference every day. Together, we belong to something beautiful.

Since its inception in 1969 in Limoges, France, and as part of the LVMH Group since 1997, Sephora has been disrupting the prestige beauty retail industry. Today, Sephora continues to break with convention to drive its mission: champion a world of inspiration and inclusion where everyone can celebrate their beauty.

With 56,000 employees in 35 countries, we connect customers and beauty brands within the world’s most passionate beauty community. With a curation of nearly 500 brands, and our own label, Sephora Collection, we offer the most unique and diverse range of products: fragrances, makeup, hair care, skincare. and much more.

You will excel and enjoy this position if you are ready to actively handle the following missions:

  • To enter data from various source documents into the computer system for processing, here on the Authorities online system related to suppliers and products.
  • Notification of Sephora Own Brand and Exclusive brands- prepares source data for computer entry by compiling and sorting information from regulatory documents such as ingredients lists / excel sheets prepared by the brands.
  • Establishing entry priorities from brands and suppliers.
  • Enters data in the online systems by inputting alphabetic and numeric information on keyboard according to screen format of the online system.
  • Maintains data entry requirements/complies with data integrity.
  • Check completed work for accuracy.
  • Lead times for product notifications.
  • Store completed documents in designed locations.
  • Maintain the registration tracking files with certificates numbers and validity dates.
  • Help and Support on the labelling Back and Forth exchanges with the brands and creation of artworks.

Do not hesitate to apply if you have:

  • Bachelor’s degree in science, pharmacy, regulatory affairs.
  • 1 to 2 years in regulatory affairs and cosmetic industry, preferably in retail or FMCG.
  • Proficiency in planning tools (RELEX, SAP, Oracle, etc.) and Microsoft Excel/Power BI.
  • Strong communication, cross-functional collaboration, and stakeholder management.
  • Data input, Ownership & Execution Focus.
  • Collaborative Communication.

Here, you will find:

  • Community. In which authenticity is embraced, and the strength of our differences fuels our collective spirit.
  • Culture of Empowerment. Learning & growth, that offers you the tools, space and opportunity to learn, innovate and lead.
  • Work that Brings Fulfilment. From delighting clients every day, to inspiring our industry at large, every action makes a difference.

Join us and belong to something beautiful

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Regulatory Affairs Coordinator

Dubai, Dubai Peergrowth Consultancy Co.

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Job Description

We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to support regulatory activities at our UAE-based manufacturing facility. This role is responsible for compiling and coordinating product and site-specific regulatory dossiers for submission to global health authorities, including support for GMP audits. The ideal candidate will collaborate closely with Quality Assurance (QA), manufacturing, and technical teams at the site, as well as regional regulatory teams. Experience with local UAE and GCC regulatory requirements is preferred, with an understanding of global CTD requirements.

KEY RESPONSIBILITIES

  • Collate, compile, and review regulatory dossiers for product and site registrations in various international markets, including GMP audit dossiers.
  • Ensure accuracy, completeness, and regulatory compliance of all documentation submitted.
  • Review and verify the correctness and regulatory alignment of Artwork (AW) prior to submission.
  • Act as a key liaison between regional regulatory teams and site-based technical functions (QA, QC, Production, Engineering).
  • Coordinate technical responses and ensure timely resolution of queries raised by health authorities during or post submission through regional RA teams.
  • Maintain an organized and up-to-date archive of all regulatory submissions made from the site.
  • Implement proper version control, submission tracking, and document retrieval protocols.
  • Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.
  • Ensure alignment with both international regulatory expectations and local UAE / GCC requirements.
  • Provide regular status updates on submissions and queries to the Head of International Regulatory Affairs.
  • Support documentation requests for internal audits, inspections, and compliance reviews.

CANDIDATE EXPERIENCE

  • Bachelors or masters degree in pharmacy (preferred)
  • 2 to5 years of experience in Regulatory Affairs, ideally in a manufacturing or site-based setting within the pharmaceutical industry.
  • Preferred : Experience with handling guidelines of UAE Ministry of Health (MoHAP), GCC-DR, Oman, Bahrain, or other Gulf regulatory bodies.
  • Practical knowledge of CTD / eCTD dossier formats and GMP audit preparation.

Key Skills and Competencies

  • Strong communication, collaboration, and coordination skills across technical and regulatory functions.
  • High level of accuracy, attention to detail, and document management capabilities.
  • Ability to manage multiple priorities, meet deadlines, and adapt to dynamic regulatory requirements.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint) and document control systems.
  • Proactive approach to problem-solving and handling regulatory queries.

Coordinator • Dubai, United Arab Emirates

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Regulatory Affairs Manager

Abu Dhabi, Abu Dhabi Abu Dhabi Islamic Bank PJSC

Posted today

Job Viewed

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Job Description

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 Info
  • 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

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Regulatory Affairs Specialist

Dubai, Dubai beBeeLegalCompliance

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Job Description

Job Description ">

We are seeking a Legal and Compliance Officer to support our company's expansion into the European Union under the Markets in Crypto-Assets Regulation (MiCA).

The successful candidate will be responsible for assisting with end-to-end license applications and regulatory coordination across selected EU jurisdictions.


The ideal candidate should have:

  • Strong knowledge of MiCA regulations and ability to apply them effectively.
  • Excellent communication skills to ensure seamless liaison with EU legal and compliance advisors.
  • Ability to research and compare different EU jurisdictions to support optimal licensing strategy.
  • Attention to detail to track regulatory updates under MiCA and ensure company alignment with supervisory expectations.

Responsibilities include supporting the full lifecycle of MiCA license applications, preparing internal materials aligned with MiCA requirements, and ensuring timely and accurate submissions.

Benefits

Flexible work location based in Dubai or a relevant EU jurisdiction. We offer competitive remuneration packages that align with industry standards.

Other Opportunities

Grow professionally in a dynamic and innovative environment. Develop expertise in EU financial regulations and stay up-to-date with industry developments.

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Regulatory Affairs Professional

Dubai, Dubai beBeeRegulatory

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Job Description

About Abbott Regulatory Specialist Position

This role works out of our UAE location in the Abbott Nutrition Division. We are looking for an experienced professional to join our team and take on a key regulatory affairs role.

  • Develop and implement regulatory strategies for product registration, ensuring compliance with local regulations.
  • Maintain existing products and support new business opportunities by analyzing and negotiating documents/positions put together as AN and within Trade Associations for current and upcoming regulations.

The ideal candidate will have experience in a regulated industry (e.g., medical products, nutritionals), excellent written English and communication skills, highly developed project management skills, and a strong analytical mindset.

  • Key Responsibilities:
    • Develop regulatory strategies for product registration, including assessing formulas, verifying label claims, and setting mitigation plans.
    • Negotiate with regulatory authorities during the review process to ensure approval.
    • Provide regulatory support to commercial division in all areas pertaining to product life-cycle management and new product development and introduction.
    • Ensure implementation of new regulations within legal deadlines.
    • Assess formulations to ensure compliance with regulations.

Requirements:

  • 4-6 years of experience in a regulated industry.
  • 3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Excellent written English and communication skills.
  • Highly developed project management skills.
  • Excellent problem-solving skills and solution-oriented mindset.
  • Business acumen.

What You'll Do-

We are committed to providing our employees with the resources they need to succeed and grow. Our comprehensive benefits package includes career development opportunities, recognition programs, and employee discounts.

Join us and contribute to shaping the future of healthcare.

Abbott is an Equal Opportunity Employer, committed to diversity.

Connect with us at

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Regulatory Affairs Coordinator

Dubai, Dubai Peergrowth Consultancy Co.

Posted 26 days ago

Job Viewed

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Job Description

We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to support regulatory activities at our UAE-based manufacturing facility. This role is responsible for compiling and coordinating product and site-specific regulatory dossiers for submission to global health authorities, including support for GMP audits. The ideal candidate will collaborate closely with Quality Assurance (QA), manufacturing, and technical teams at the site, as well as regional regulatory teams. Experience with local UAE and GCC regulatory requirements is preferred, with an understanding of global CTD requirements.

KEY RESPONSIBILITIES

  • Collate, compile, and review regulatory dossiers for product and site registrations in various international markets, including GMP audit dossiers.
  • Ensure accuracy, completeness, and regulatory compliance of all documentation submitted.
  • Review and verify the correctness and regulatory alignment of Artwork (AW) prior to submission.
  • Act as a key liaison between regional regulatory teams and site-based technical functions (QA, QC, Production, Engineering).
  • Coordinate technical responses and ensure timely resolution of queries raised by health authorities during or post submission through regional RA teams.
  • Maintain an organized and up-to-date archive of all regulatory submissions made from the site.
  • Implement proper version control, submission tracking, and document retrieval protocols.
  • Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.
  • Ensure alignment with both international regulatory expectations and local UAE/GCC requirements.
  • Provide regular status updates on submissions and queries to the Head of International Regulatory Affairs.
  • Support documentation requests for internal audits, inspections, and compliance reviews.

CANDIDATE EXPERIENCE

  • Bachelors or masters degree in pharmacy (preferred)
  • 2 to 5 years of experience in Regulatory Affairs, ideally in a manufacturing or site-based setting within the pharmaceutical industry.
  • Preferred: Experience with handling guidelines of UAE Ministry of Health (MoHAP), GCC-DR, Oman, Bahrain, or other Gulf regulatory bodies.
  • Practical knowledge of CTD/eCTD dossier formats and GMP audit preparation.

Key Skills and Competencies

  • Strong communication, collaboration, and coordination skills across technical and regulatory functions.
  • High level of accuracy, attention to detail, and document management capabilities.
  • Ability to manage multiple priorities, meet deadlines, and adapt to dynamic regulatory requirements.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint) and document control systems.
  • Proactive approach to problem-solving and handling regulatory queries.
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Director of Regulatory Affairs

Abu Dhabi, Abu Dhabi beBeeRisk

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Job Description

Job Summary:

We are seeking a seasoned Risk Management professional to lead our Basel Analytics team.

Key Responsibilities:
  • Supervise the execution of ICAAP by planning and coordinating stakeholders, financial modeling, and report preparation for Senior Management and the Board.
  • Lead enterprise-wide regulatory and internal stress testing exercises, interpreting technical requirements, assessing economic stresses, and reviewing output.
  • Contribute to reviewing scenario construction and statistical models, as well as developing, maintaining, and using capital-related models.
  • Support model validation framework implementation in line with IFRS9 and Basel Requirements.
Requirements:
  • 10-15 years of relevant Risk Management experience.
  • Professional finance/risk qualifications (CA, ACCA, FRM, CFA, PRM).
Preferred Skills:
  • Robust knowledge of risk management best practices and regulatory requirements.
  • Excellent analytical and research skills.
  • In-depth knowledge of risk policies and practices.
  • Expert level understanding of Financial Reporting Standards.
  • Ability to work independently on multiple tasks and/or projects.
  • Excellent oral and written communication skills.
  • Team player and able to work under pressure.
Education:

Bachelor's/Master's degree in relevant field.

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Global Regulatory Affairs Manager (homebased)

Dubai, Dubai IQVIA

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Job Description

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

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