Regulatory Affairs Officer

We are looking for Regulatory Affairs Officer to represent the company in regulatory matters, prepare registration dossiers, and gather necessary documents, data, and samples from relevant departments for submission. Ensure batch release activities, validate artworks, and prepare leaflet texts, ensuring all materials use the correct references.

Your Responsibilities :

Regulatory Compliance and Documentation :

• Ensure batch release activities and prepare, update, and manage all necessary documents for registration and post-approval changes.
• Edit the Summary of Product Characteristics and verify compliance with guidelines.
• Use technical software for documentation and official correspondence.

Coordination with Authorities:

• Maintain communication with health authorities to expedite approvals and handle regulatory inquiries.
• Collect, archive, and manage regulatory correspondences and approvals.

 Quality and Change Control :

•  Assess, review, and approve change controls, deviations, and quality documents related to the product.
• Check compliance of received Drug Master Files and Bioequivalence studies reports.

 Artwork and Labeling:

•  Prepare and translate product leaflets and artworks, ensuring accuracy per health authority requirements.
•  Coordinate with designers and relevant departments to finalize artworks.

Required Profile :

Education : University degree in Pharmacy.

Experience: At least 3 years of experience in a similar role.

Planning and Organizational Skills:

-Plan, organize, and manage multiple tasks to meet deadlines.

-Develop and send periodic reports on departmental activities and handle additional tasks as requested by the supervisor.

Why Join Us? By joining our team, you become part of a dynamic and growing company that values knowledge, attitude, and motivation. You will have the opportunity to make a real impact while working in an environment that fosters continuous learning and career advancement.

Ready to shape the future of the pharmaceutical industry with us? Apply today!