We are looking for a Regulatory Affairs Specialist. The Position will be reporting to Regulatory Affairs Manager and will be responsible to ensure appropriate licensing and compliance of all our products (Pharmaceuticals, Nutraceutical, Medical Devices, Cosmetics, etc.) with UAE / Regional authorities regulations and guidelines in an excellent manner that can support and differentiate our services and business in the market.
Key Responsibilities:
- Achieve the targeted number of all planned regulatory activities (New submissions, Minor Variations, and Renewals, etc…) with all regulatory authorities in full alignment with business internal and external stakeholders.
- Ensure high quality of daily business activities and tasks (Review, submission, follow up, complexity handling, etc…) in the outstanding timeline
- Comply with UAE Authorities (MOH, DM, ESMA, etc…) and the company’s SOPs/policies.
- Ensure high quality and accuracy of regulatory reports and updates on a monthly/quarterly basis with strong tracking of all regulatory activities/records
- Ensure a professional approach and effective communication with internal and external stakeholders.
- Establish a strong relationship with internal and external stakeholders (Authorities, Principles, etc.)
- Support AKI supply/ logistics teams and business development departments across AKI division in all topics related to regulatory
Experience & Qualification:
Minimum 3 years of experience in regulatory/ or related experience.
Bachelor’s Degree in Pharmacy Or Equivalent Experience
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