Biocon - Assistant General Manager - Regulatory Affairs - API

Key responsibilities:

- Ensuring smooth regulatory approvals by filing adequate and zero deficient DMFs globally.

- Review of compiled DMFs (in eCTD or NeeS format) for all small molecule APIs for various markets and submission of the same with relevant Regulatory agencies globally.

- Compilation, review and submission of Response to Queries raised by Regulatory agencies globally.

- Compilation, review and submission of Response to Queries raised by customers.

- Review and submission of Annual Reports to the Regulatory agencies as applicable.

- Evaluation of cost improvement plans and filing required Amendments/variations accordingly

- Update / train the Regulatory Sciences team for SM-API on Regulatory guidelines.

- Support to National Regulatory Affairs and Biocon Vizag.

- Participation in inspection by Regulatory agency on need basis.

Educational Qualification & Experience : M.Sc/M.Pharm with more than 14 Years experience in managing team; handling regulatory affairs activities for API business globally.

Behavioural/Managerial skills:

- Key strength shall be to provide efficient leadership for the technical and scientific team of people.

- Ability to communicate and influence to achieve delivery of objectives often to tight deadlines.

- To be able to maintain healthy rapport with internal & external stake-holders.

- Business acumen, Interpersonal Skills, and Result Orientation is something person must have.

- Thrive to achieve overall business goals for the organization with passion & self-motivation.