Regulatory Affairs Job at Intas| MPharm Graduates Apply Now
Intas Biopharma is inviting ambitious professionals to join its future growth story in Ahmedabad. The company is hiring for the position of Executive / Sr. Executive in Regulatory Affairs (RA). This Regulatory Affairs Job requires an M.Pharm, M.Sc (Biotech), or M.Tech (Biotech) with 2 to 10 years of experience, preferably in the Biosimilars sector. The successful candidate will manage global regulatory dossiers, MAAs, and USFDA filings, ensuring compliance and strategic alignment throughout the product development lifecycle.
- Position: Regulatory Affairs (Executive / Sr. Executive)
- Job Location: Intas Biopharma Plant, Ahmedabad
About The Company
Intas Pharmaceuticals is a leading multinational pharmaceutical company that is rapidly expanding its Biopharmaceutical capabilities. Known for its world-class manufacturing facilities and R&D centers, Intas is a major player in regulated markets like the US and EU. The company focuses on the development and commercialization of complex generics and biosimilars, driven by a commitment to high-quality standards and innovative therapeutic solutions.
Regulatory Affairs Job Description
- Authorise and review regulatory dossiers for submissions across US, EU and other regulated and emerging markets.
- Review documents, source data, and inputs for regulatory submissions, including MAAs, USFDA filings, and variation applications.
- Provide regulatory support during early and late stages of product development to ensure compliance and strategic alignment.
- Ensure timely submission of Marketing Authorization Applications (MAAs) and related documents across global markets.
- Collaborate with cross-functional teams (CFTs) and subject matter experts (SMEs) to efficiently resolve queries from health authorities.
- Manage lifecycle activities for approved products to maintain regulatory compliance and support post-approval changes.
- Maintain and update tracking systems (e.g. query tracker, MAA status tracker) for ongoing regulatory submissions and commitments.
- Review and provide inputs on source documents required for authoring MAAs, variation applications, and other regulatory submissions.
- Ensure quality deliverables from the team, meeting internal standards and regulatory expectations.
Qualifications required for the MPharm Job
M.Pharm
Experience
2 Years to 10 Years (Preferably in Biosimilars – RA)
