Regulatory Affairs Specialist
Role Details
The role has primary responsibility for supporting all local regulatory affairs workflow including preparation of dossiers and applications for new registration and maintain existing products life-cycle as well as applying the pharmacovigilance policy under the supervision by line Manager.
The Role
Support RA and QA team in:
Preparation of dossiers and applications to register new products and maintain existing products life- cycle
Preparation of parallel import applications for national and central import procedures.
Supporting the relationships with local regulatory authorities to achieve positive outcomes for new product registrations, variations, renewals, notifications.
Submission of Life Cycle Management changes (variations, marketing status, sunset clause, renewals and line extensions)
Artwork revision process, i.e. requesting, proof reading, approval and implementation of artwork
Close cooperation with supply chain and marketing department to ensure product launch and marketing materials approval from regulatory perspective.
The Person
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At least 6 months 1-year professional experience on similar position or internship in RA Department in pharmaceutical company or national competent authority
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Knowledge of pharmaceutical law and the required documentation for pharmaceutical product
The Rewards
How to Apply
A Bit About Us
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All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
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