Senior Executive, Regulatory Affairs, Pre Approval Injectable USA Market

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.