About the role
- Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market.
- Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market.
- Draft and finalize controlled correspondences on complex issues.
- Draft, Review and Finalize Deficiency responses for Complex Products and 505(b)(2) Products.
- Review API and FP in-vitro characterization/sameness reports.
- DMF review for complex APIs as per the workflow.
- To collaborate and work closely with cross functional teams.
- To meet the management expectations w.r.t timelines and quality.
- To work closely within the team and provide training to new members on new regulatory requirements for Complex products.