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 (Healthy Consumer Section), Dubai Municipality (Food Department), and relevant standards/competent authorities (e.g., ESMA legacy requirements where applicable).
- Receive, review, and submit regulatory files for: new registrations, renewals, variations (minor/major as applicable), 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.
- Provide cross-functional support to internal teams when required.
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.
