Regulatory affairs

M.Sc / M.Pharm. Review & prepare CMC Chemistry, Manufacturing and Controls dossiers for fresh submissions. at Sun Pharma

The theme of the conference, explores how the pharmaceutical industry can drive positive change by implementing sustainable practices, advancing green chemistry, reducing environmental impact and enhancing access to life-saving medicines

Represent the company at industry events, meetings and conferences. Track and analyse sales data to identify trends and opportunities for growth

Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.

Regulatory Affairs Executive is responsible contribute regulatory expertise in various aspects including regulatory submissions, right first-time dossiers, timely addressal of queries, etc. for various product categories such as Cosmetics, Commodities etc.

Assist in the preparation of response packages to Health Canada requests in a timely manner to minimize delays in the submission review process. 

BS degree in Pharmacy or Life Sciences or relevant education. Minimum 1 year of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.

Preparation, review and submission of Dossiers, Good exposure on Life Cycle Management. Handling Post approval & Pre approval

The Manager, Regulatory Affairs – CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products.