Biocon - Assistant General Manager - Regulatory Affairs - API (14-15 yrs)
- 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.
- 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.