Senior Executive, Regulatory Affairs
10 hours ago
KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
- Prepare 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 Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market.
- Draft controlled correspondences on complex issues.
- Draft 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.
MINIMUM REQUIREMENTS:
- Suitably qualified individuals with strong Scientific and Regulatory background.
- Academic degree in Pharmacy (M. Pharm), with preferably specialization in Regulatory Affairs or Pharmaceutics.
- Experienced (minimum 3 years) in Regulatory Affairs and having hands-on experience in Injectable dosage form that includes (but not limited to) submission of ANDA, responding to deficiencies, FDA communications etc.
- 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.
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