Lupin Limited (Biotech Division) Job Vacancy For Regulatory Affairs dept for Pune location.

Lupin Limited (Biotech Division) Job Vacancy For Regulatory Affairs dept for Pune location.

Lupin Limited (Biotech Division) Job Vacancy For Regulatory Affairs dept for Pune location.

Lupin Limited (Biotech Division) is looking for Manager in Regulatory Affairs dept for Pune location.

Qualification : M. Pharm. / M. Tech / M.Sc. (Life sciences, Biotechnology)

Experience: 8 - 10/8-10/9-11 yrs. of relevant exp in Biosimilars. Short Job description:

1. Responsible to draft the regulatory submission files such as scientific advice package, BPD meeting package, IND, IMPD, pre-submission meeting package, eCTD sections. To provide the regulatory requirements for bio-similar products for global development.

2. Drafting and/or review of the CTD sections as per different geography regulatory requirements and life cycle management of products. Addressing the comments/ queries received on CTD sections from Regulators, CFTS, SMEs and customer/s.

3. Review of different documents from different cross functional teams, required for submission. Coordinate to get the relevant source documents required for the submissions.

4. Create and maintain product regulatory history documents and communicating to the internal team accordingly. Archival of all regulatory documents and agency communications.

5. Ensure compliance via timely submissions to regulatory agencies. Coordinate collection of functional documents in support of regulatory applications.

4. Product lifecycle management activities in various regulated markets (such as EMA, USFDA, Canada etc.)

5. Must have the regulated market exposure for biosimilars products at different development stages and post market filings. Global regulated market filing exposure is preferred for microbial and mammalian platforms both.

If interested, please share your CV to gurpreetchandok@lupin.com Request all the connections to share and like this to reach maximum people.