Regulatory Affairs Officer
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Key skills for this role
About the Role
A reputable local distributor is seeking an experienced Regulatory Affairs Associate to manage end-to-end regulatory submissions and lifecycle maintenance across multiple product categories in the UAE.
Key Skills for This Role
Responsibilities
- Manage registration and lifecycle submissions for multiple product categories across UAE authorities
- Receive, review, and submit regulatory files for new registrations, renewals, variations, classification, repricing, endorsement, cancellation, and updates
- Handle submissions related to MAH and manufacturing site registration/renewal/variations
- Perform document completeness and compliance checks and communicate deficiencies to principal companies
- Coordinate with principal companies on Module 1 preparation in line with UAE requirements
- Track renewal timelines proactively to avoid delays and ensure continuity of importation/supply
- Coordinate EDE Quality Control Laboratory submissions and follow up on technical requirements
- Manage post submission activities: receive authority comments, coordinate responses, and ensure timely resubmissions
- Receive and circulate approval certificates internally and to principal companies; maintain regulatory trackers and records
- Monitor and communicate new circulars, ministerial decrees, and regulatory updates impacting the portfolio
- Maintain professional relationships with Drug Department / authority stakeholders and support urgent cases
- Support principal company meetings and provide cross functional support to internal teams
Requirements
- Bachelor's Degree in Pharmacy (mandatory)
- 2 3 years of experience in Regulatory Affairs in the UAE (similar role and scope)
- Strong knowledge of UAE regulatory pathways and authority expectations
- Strong planning, organization, and documentation discipline
- Excellent communication and stakeholder management skills
- Good computer skills and ability to manage multiple trackers/submissions in parallel
Full Job Posting
Job Overview
- A reputable local distributor is looking for an experienced Regulatory Affairs Associate to manage end to end regulatory submissions and lifecycle maintenance across multiple product categories and UAE authorities.
- The role will work closely with principal companies and internal teams to ensure timely approvals, compliance, and uninterrupted product supply.
Key Responsibilities
- Manage registration and lifecycle submissions for multiple product categories (Conventional medicines, GSL, Medical Devices, Cosmetics, Food Items) across UAE authorities, including EDE, Dubai Municipality, and relevant standards/competent authorities.
- Receive, review, and submit regulatory files for: new registrations, renewals, variations, classification, repricing, endorsement, cancellation, and updates related to patency/exclusivity and dispensing status.
- Handle submissions related to MAH and manufacturing site registration/renewal/variations, as applicable.
- Perform document completeness and compliance checks and communicate deficiencies to principal companies with clear corrective guidance.
- Coordinate with principal companies on Module 1 preparation in line with UAE requirements.
- Track renewal timelines proactively to avoid delays and ensure continuity of importation/supply; escalate risks early.
- Coordinate EDE Quality Control Laboratory submissions (quality documents and/or samples), follow up on technical requirements, and support until final analysis approval.
- Manage post submission activities: receive authority comments, coordinate responses with principals, and ensure timely resubmissions.
- Receive and circulate approval certificates internally and to principal companies; maintain regulatory trackers and records.
- Monitor and communicate new circulars, ministerial decrees, and regulatory updates impacting the portfolio.
- Maintain professional relationships with Drug Department / authority stakeholders and support urgent cases (e.g., shipment release support where regulatory clarification is required).
- Support principal company meetings and alignment on current/future projects and authority expectations.
Requirements
- Bachelor's Degree in Pharmacy (mandatory)
- 2 3 years of experience in Regulatory Affairs in the UAE (similar role and scope)
- Strong knowledge of UAE regulatory pathways and authority expectations
- Strong planning, organization, and documentation discipline
- Excellent communication and stakeholder management skills
- Good computer skills and ability to manage multiple trackers/submissions in parallel.
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