Experience spanning three decades in healthcare, with a wide range of formulations to meet the needs of ailing humanity, Intas Pharmaceuticals headquartered at Ahmedabad (India), is now a force to reckon with, in the global pharma horizon. With expertise in a range of formulations, from tablets to injectables to newer drug delivery systems, Intas is currently ranked 17th among the Indian Pharma majors. A variety of initiatives in Research and Development, patents and ANDA filing, NDDS, quality manufacturing support, along with approvals by regulatory authorities of many countries has made Intas a global healthcare provider.
Job Title : Senior Executive – Regulatory (biosimilars)
Eligiblity : M.Sc. / M.Pharma / M. Tech / PhD Bio-Chemistry/Bio-Technology
Experience : 3 – 7 Years
No of Openings : 3
Job Description
1. Preparation of applications and documents for registration of Recombinant Products in Regulated and Semi-Regulated Countries.
2. Preparation of documents required for RA Compliance CMC guidelines / Dossier preparation guidelines and Assisting in CMC Compliance activities.
3. Coordination with customers, and regulatory bodies of various countries.
4. Participates in the multi-disciplinary product development sub-teams as a representative of the RA for providing regulatory support for the ongoing projects.
Desired Profile
- M.Sc. / M.Pharma / M. Tech with 3 – 7 Years of experience in Regulatory submission of Biosimilar Products in Regulated / Semi – Regulated Markets
- A Candidate should have good inter-personal skills and able to work closely with cross functional teams.
- A Person should have good understanding of current Regulatory guidelines
Location : Ahmedabad
