Manager, Regulatory Affairs (Pre Approval)

Role Overview: As a Regulatory Affairs Specialist at the company, your main responsibility will be to prepare, review, and finalize regulatory strategies for complex products such as injectables, ophthalmic, otic, topical gel, DDCP, etc., along with 505(b)(2) products for regulated markets like the US, Canada, and EU. You will be drafting, reviewing, and finalizing various regulatory documents including Pre-ANDA/Pre-IND/ScA/Scientific meeting packages, controlled correspondences, and deficiency responses for complex products. Additionally, you will collaborate with cross-functional teams, meet management expectations regarding timelines and quality, and provide training to new team members on regulatory requirements. Key Responsibilities: - Prepare, review, and finalize regulatory strategies for complex products and 505(b)(2) products for regulated markets - Draft, review, and finalize Pre-ANDA/Pre-IND/ScA/Scientific meeting packages and follow up communications - 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 - Collaborate with cross-functional teams and meet management expectations on timelines and quality - Provide training to new team members on regulatory requirements for complex products Qualifications: - Suitably qualified individuals with a strong scientific and regulatory background - Academic degree in Pharmacy (M. Pharm or PhD) with specialization in Regulatory Affairs or Pharmaceutics preferred - Minimum 10 years of experience in Regulatory Affairs and overall experience of 12+ years,