Deputy Manager – Regulatory Affairs (Complex Products)
Location: Gujarat, India
Experience Required: 8–10 years in Regulatory Affairs (12+ years overall preferred)
Industry: Pharmaceuticals | Regulatory Affairs | CMC
Employment Type: Full-time
Job Overview
We are seeking an experienced Deputy Manager – Regulatory Affairs with strong expertise in complex pharmaceutical products and 505(b)(2) submissions for the US and EU markets. The role involves end-to-end regulatory strategy development, dossier preparation, agency interactions, and cross-functional collaboration to ensure timely and compliant submissions.
Key Responsibilities
Develop, review, and finalize regulatory strategies for complex products, including injectables (peptides, microspheres, liposomes, nano-suspensions), ophthalmic, otic, topical gels, DDCPs, and 505(b)(2) products for US and EU markets.
Draft, review, and finalize Pre-ANDA, Pre-IND, Scientific Advice (ScA) meeting packages for regulatory agencies.
Prepare and manage controlled correspondence addressing complex regulatory issues.
Draft, review, and submit deficiency responses for complex and 505(b)(2) products.
Review API and finished product in-vitro characterization and sameness reports.
Perform DMF reviews for complex APIs in accordance with defined regulatory workflows.
Collaborate closely with cross-functional teams including R&D, Quality, Manufacturing, and Analytical teams.
Ensure compliance with regulatory timelines, quality standards, and management expectations.
Mentor and train team members on new and evolving regulatory requirements for complex products.
Apply sound regulatory judgment on quality, compliance, and technical matters, ensuring adherence to global guidelines.
Skills and Competencies
Strong understanding of US FDA, EMA, ICH guidelines, and global regulatory frameworks.
Proven expertise in complex injectable dosage forms and lifecycle management.
High-level scientific writing and regulatory documentation skills.
Strong analytical thinking, problem-solving ability, and attention to detail.
Excellent collaboration skills with experience working in matrix organizations.
Solution-oriented mindset with a strong sense of ownership, accountability, and compliance.
Ability to prioritize multiple projects in a fast-paced regulatory environment.
Qualifications
Education:
Master’s degree in Pharmacy (M. Pharm) or PhD, preferably with specialization in Regulatory Affairs or Pharmaceutics.
Experience:
Minimum 8–10 years of relevant Regulatory Affairs experience in injectable dosage forms.
Overall industry experience of 12+ years preferred.
Demonstrated end-to-end experience in regulatory strategy, filings, deficiency responses, and agency interactions for US/EU markets.
About the Company
Amneal is an equal opportunity employer committed to diversity and inclusion. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We strive to create an inclusive workplace that values integrity, collaboration, and professional excellence.
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