Openings in Regulatory Affairs at Adaptis Pharma

Adaptis, we provide comprehensive solutions that empower healthcare companies, ensuring success across global markets with expert consulting in pharmacovigilance and regulatory affairs.

Post : Senior Executive

Senior Executive II - Drug Product Regulatory Affairs
Experience : 4-6 years
Job Description : Preparation of injectable/ophthalmic dosage form ANDA sections as per the regulatory guidelines and timelines.
• Review and filing of query response, annual reports, supplements for all approved products (specifically injectables/opthalmics) for US market.
• Review of the development documents and CMC documents as per regulatory standards.
• Gathering, managing and collating information from respective stake holders.
• Keeping up to date with changes in regulatory legislation and guidelines in respect of the US market.

Senior Executive I - Medical Device Regulatory Affairs
Experience : 3-5 years
Job Description : • Review of documents for medical device submission in USA/EU region.
• 510 (k) application sections writing.
• Compilation of 510(k) as per regulatory authority requirements.
• Guidance to client team on medical device requirements, if need be.
• Monitor applicable global regulatory requirement and updates.
• Authority query analysis and response during medical device application review

Job Location : Pune