- 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.
- Suitably qualified individuals with strong Scientific and Regulatory background.
- Academic degree in Pharmacy (M. Pharm or PhD), with preferably specialization in Regulatory Affairs or Pharmaceutics.
- Experienced (minimum 8-10 years) in Regulatory Affairs with Injectable dosage form and overall experience 12+ years.
- End to end complete understanding of Complex Products for US/ EU market right from Strategy, Filing, Deficiency response etc.
- Experienced in drafting controlled correspondences, Meeting packages etc.
- Experience being an active contributor to cross-functional teams and/or working in matrix organizations. High quality, critical thinking, process, and performance orientated; prioritizes activities and projects.
- Exercises good judgment on regulatory, quality, and technical related compliance issues. High personal integrity; trustworthy; strong compliance and quality mind-set.
- Solution orientated, strong sense of ownership and accountability.
- Collaborative, team-oriented approach, capable of working cross-functionally, and in a matrixed and integrated way.
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
