Felix Pharmaceuticals - Manager - Regulatory Affairs - CMC

Primary Job Responsibilities:

- CMC review and submission of drug products to different territories by complying necessary regulatory requirement of regulatory authorities such as US, EU, Canada etc.)

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

- To coach and train a small group on submission requirement and ensure they completely understand the process and requirements.

Detailed Job Description

- Review of CMC documents (PDR, Dissolution discriminatory report, Split study report, BMRs/BPRs, PV Protocols/Reports, hold time protocol/report, Specifications, MoA, Method validation protocols/reports, Stability protocol/data etc.) to ensure that documents do conform with regulatory guidelines.

- Reviewing and finalizing the registration dossiers (CMC Part) independently as per the agency requirements for submission to regulatory authority.

- Responding queries raised by Regulatory Agencies to facilitate registration approval.

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

- Assessment of change controls related to product and process development to ascertain regulatory filing strategy and data requirement to facilitate registration approval.

Skills Required

- Must have: Sound knowledge of regulatory guidelines applicable for registration of dossier in different territories and

- Add on: Understanding of life cycle management requirements of various regulatory agencies

- Experience of handling the Drug Product Registration/Submission activities with USFDA, EU and Health Canada authorities etc.

- Good understanding about the criticality involved in Development and Registration of drug products with respect to business and compliance perspective