Deputy Manager – Regulatory Affairs, Injectable US Market
Location: Ahmedabad, Gujarat, India
Employment Type: Full-Time
Experience Required: 8–10 years in Regulatory Affairs, with hands-on experience in complex injectable and ophthalmic-otic products
Education: M.Pharm or equivalent
Application Deadline: 28 February 2026
Position Overview
We are seeking a highly skilled Deputy Manager – Regulatory Affairs to manage regulatory activities for complex injectable and ophthalmic-otic dosage forms targeting the US market. The ideal candidate will have extensive experience in CMC regulatory submissions, ANDA/505(b)(2)/NDA filings, and cross-functional coordination across US, EU, and Canadian markets. This role requires strategic oversight of regulatory strategy, dossier compilation, and submission management for both general and complex products.
Key Responsibilities
Lead the preparation, review, and submission of regulatory dossiers for general and complex injectable and ophthalmic-otic products in compliance with USFDA, EMA, and Health Canada requirements.
Compile and review quality sections of ANDAs, NDAs, 505(b)(2) applications, and related amendments or query responses within set timelines.
Prepare and review Pre-ANDA, Pre-NDA, and meeting packages for regulatory authorities.
Conduct primary review of DMFs for injectable APIs and follow up with purchase or vendor teams for documentation.
Review technical documents from PD, ARD, QA, QC, Production, and CROs for inclusion in regulatory submissions.
Prepare and review controlled correspondence and regulatory white papers for complex injectable products.
Coordinate with cross-functional teams including R&D, ARD, QC, QA, Clinical, and Labeling to ensure timely completion of technical and regulatory tasks.
Monitor changes in global regulations, guidance, and procedures, evaluating their impact on product life cycle and submission strategy.
Escalate critical issues to superiors and provide recommendations to maintain submission timelines and regulatory compliance.
Required Skills and Competencies
Strong knowledge of regulatory CMC requirements for complex injectable and ophthalmic-otic dosage forms.
Hands-on experience with US, EU, and Canada dossier submissions.
Expertise in ANDA, NDA, 505(b)(2) filings, amendments, and deficiency responses.
Ability to prepare and review meeting packages, controlled correspondence, and regulatory strategy documents.
Excellent communication skills, both written and verbal, with the ability to collaborate across global teams.
Strong organizational, analytical, and problem-solving skills to manage multiple projects in a fast-paced environment.
Proactive, solution-oriented approach with strong sense of ownership and accountability.
Qualifications & Experience
Master’s degree in Pharmacy (M.Pharm) or equivalent; PhD is an advantage.
Minimum of 8–10 years of regulatory affairs experience, specifically with injectable or ophthalmic-otic dosage forms.
Proven track record in US regulatory submissions and cross-functional project management.
About Us
Amneal is committed to fostering a diverse and inclusive workplace. We do not discriminate based on caste, religion, gender, disability, or any legally protected status. Our Human Resources team ensures effective people management, strategic input, compliance, and workforce development to support organizational goals.
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