BDR Pharmaceuticals - Assistant Manager/Deputy Manager - Regulatory Affairs

Key Responsibilities:

- Develop and direct global regulatory strategies covering clinical, non-clinical, and CMC aspects.

- Lead the preparation, review, and approval of submission dossiers for regulatory authorities including US FDA, EMA, Health Canada, Australia's TGA, and ANVISA (Brazil).

- Provide strategic guidance on regulatory pathways related to CMC changes and ensure appropriate regulatory compliance.

- Collaborate with cross-functional teams including Quality, Manufacturing, Clinical, and R&D to ensure timely and compliant regulatory submissions.

- Manage timelines and coordinate with regulatory agencies to facilitate approvals.

- Participate in client interactions, trainings, and regulatory development initiatives as required.

- Lead and manage the regulatory affairs team, driving productivity and compliance.

Qualifications & Skills:

- 12 to 15 years of relevant experience in regulatory affairs, preferably within the pharmaceutical or related industries.

- Proven experience in developing and implementing regulatory strategies at a global level.

- Strong proficiency in preparing and submitting regulatory documentation to major health authorities (US FDA, EMA, Health Canada, TGA, ANVISA).

- Deep understanding of regulatory compliance requirements and industry best practices.