Senior Executive, Regulatory Affairs, Pre Approval Injectable USA Market

Role Overview: As a Regulatory Affairs Specialist at Amneal, your primary responsibility will be to prepare regulatory strategies for complex products such as injectables, ophthalmic, otic, topical gel, and 505(b)(2) products for both the US and EU markets. You will be drafting Pre-ANDA/Pre-IND/ScA meeting packages, controlled correspondences, and deficiency responses for complex products. Additionally, you will review API and finished product in-vitro characterization reports, collaborate with cross-functional teams, and ensure compliance with regulatory standards. Key Responsibilities: - Prepare Regulatory strategies for Complex Products including injectables, peptides, microspheres, liposomes, nano-suspensions, etc., as well as 505(b)(2) Products for the US and EU market. - Draft Pre-ANDA/Pre-IND/ScA meeting packages for the 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. - Collaborate and work closely with cross-functional teams. Qualifications: - Suitably qualified individuals with a strong Scientific and Regulatory background. - Academic degree in Pharmacy (M. Pharm), preferably with a specialization in Regulatory Affairs or Pharmaceutics. - Minimum 3 years of experience in Regulatory Affairs with hands-on experience in Injectable dosage forms, including submission of ANDA, responding to deficiencies, and FDA communications. - Possess good judgment on regulatory, quality, and technical compliance issues. - Demonstrate high personal integrity, trustworthiness, and a strong compliance and quality mindset. - Solution-oriented with a strong sense of ownership and accountability. - Collaborative and team-oriented approach, capable of working cross-functionally and in a matrixed and integrated way. (Note: Additional details about the company and the Human Resources team have been omitted as per the instructions),