Felix Pharmaceuticals - Deputy Manager/Manager - Regulatory Affairs - Life Cycle Management

Primary Job Responsibilities:

- Life cycle management of approved drug products (by various regulatory authorities) to ensure that drug product(s) and process remain in compliance as per Agency's post approval guidelines and requirements.

- Submission of supplement/variation to different territories by complying necessary regulatory requirement of regulatory authorities such as US, EU, Canada etc.)

- To ensure that submission are error free, accurate and do comply as per Agency's guidelines, requirements and internal procedure and checkpoints.

- Training to the concern persons per current FDA guidance and other updates.

Detailed Job Description

- Authoring and review of Supplement submission CBE-30, PAS and Annual reports and life Cycle Management.

- Assessment of change controls related to product and process changes to ascertain regulatory filing strategy and data requirement to meet post approval regulatory requirements.

- Coordination with concerned stake holders for continuous monitoring of planned/unplanned changes in the product and process after product approval.

- Compilation, review and submission of MCSR reports, Submission of drug experience reports (DERs), Submission of labeling changes, Submission of Variations, Submission of CMC supplements, Drug listing and facility registration, etc.

- Responding queries raised by Regulatory Agencies to maintain the registration approvals.

- Coordination with various departments like Quality Control & Quality Assurance, Production and Stability departments based at R&D, Felix Plant, CRO & CMO site for facilitating the life cycle management of Products.

Skills Required

- Sound knowledge of regulatory guidelines and life cycle management requirements of various regulatory agencies

- Experience of handling the post approval activities with USFDA, EU and Health Canada authorities etc.

- Able to work under pressure

- Good understanding about the criticality involved in life cycle management of drug products with respect to business and compliance perspective