Job for Regulatory Affairs Officer at Glenmark

Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in markets across emerging economies including India. The generics business services the requirements of developed markets like US and Western Europe. Our API business sells products in over 65 countries including the US, various countries in the EU, South America and India.

Post : Officer - Regulatory Affairs

PROFILE SUMMARY
The objective of the role is co-ordinate and ensure timely submissions of Supplements i.e CBE-0, CBE-30 and Prior Approval Supplements (PAS) to US FDA, using appropriate guidance and regulation to maintain product lifecycle. Should have worked on PLCM activities like Supplements - PAS, CBE-30, CBE-0, and Annual Reports. Experience of 2-3 years preferred.

Roles & Responsibilities
Evaluation of change control (CC) from manufacturing sites for APIs/Finished Product/Excipients etc Evaluation of reduced testing proposals for APIs/excipients/ln- process specifications. Review and compilation of documents required for supplement/Annual report Co-ordinate with different internal and external stakeholders for the data required for filing of various applications. Evaluation of proposals related to alternate APIs/excipients/packaging material. Evaluate various drug product site transfer proposals. To maintain various post approval databases for supplements, annual reports and keep them updated at all times. Keep updated with various guidelines from Health authorities. Timely response to the pharmacist query.

SKILLS
Basic knowledge and experience in post approval life cycle management of US. Worked on PLCM activities like Supplements - PAS, CBE-30, CBE-0, and Annual Reports/Variations for emerging markets Sound knowledge in reviewing formulation and Analytical documents with respect to various dosage forms like oral solids/topical formulations/injectables

Additional Information
Experience : 02-03 years
Qualification : M.Pharm, B.Pharm
Location : Head Office, Andheri
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th May, 2021