Deputy Manager – Regulatory Affairs (Injectables, US Market)
Location: Ahmedabad, Gujarat, India
Work Type: Full-Time, Onsite
Job ID: 6715
Apply By: 28 February 2026
Degree Required: Master’s Degree
Department: Regulatory Affairs
About Amneal
Amneal Pharmaceuticals is a leading global pharmaceutical organization, committed to delivering high-quality, innovative medicines to patients worldwide. We emphasize regulatory excellence, scientific rigor, and cross-functional collaboration to ensure timely access to medicines in regulated markets, including the US, Europe, and Canada. Amneal values diversity and inclusion, fostering a workplace where talent and innovation thrive.
Role Overview
The Deputy Manager – Regulatory Affairs (Injectables, US Market) will play a critical role in leading regulatory submissions, dossier management, and compliance for general and complex injectable and ophthalmic-otic products. This role requires hands-on expertise in CMC (Chemistry, Manufacturing, and Controls) activities, regulatory strategy, and coordination across global markets. You will ensure regulatory deliverables meet stringent timelines, quality standards, and USFDA/EMA/Health Canada requirements.
Key Responsibilities
Lead regulatory CMC activities for parenteral dosage forms, including complex injectables and ophthalmic-otic products.
Compile, review, and manage ANDAs, NDAs, MAA, ANDS, and 505(b)(2) submissions in compliance with US, European, and Canadian regulatory frameworks.
Prepare and review meeting packages, amendments, query responses, and controlled correspondences for regulatory filings.
Coordinate with cross-functional teams including R&D, ARD, QA, QC, Clinical, Labeling, and Production to ensure completion of technical and regulatory tasks.
Conduct primary review of Drug Master Files (DMFs) and follow up with vendors for documentation compliance.
Develop and review regulatory strategies, white papers, and lifecycle management plans for injectable and ophthalmic-otic products.
Monitor regulatory changes, evaluate impacts on product lifecycle, and implement compliant strategies.
Maintain documentation accuracy and compliance, ensuring timely submissions aligned with regulatory timelines.
Required Qualifications & Experience
Master’s degree in Pharmaceutical Sciences, Chemistry, or Life Sciences.
5–8 years of hands-on regulatory affairs experience in the pharmaceutical industry, with a focus on US injectable and ophthalmic-otic products.
Proven experience with US, European, and Canadian dossier submissions, including ANDAs, NDAs, and 505(b)(2) pathways.
Strong expertise in CMC regulatory submissions, regulatory strategy development, and cross-functional coordination.
Familiarity with preparing meeting packages, amendments, DMFs, and controlled correspondences.
Excellent understanding of regulatory procedures, guidance documents, and compliance requirements.
Strong project management, analytical, and communication skills with attention to detail.
Skills & Competencies
Ability to manage multiple regulatory projects and meet tight submission deadlines.
Strong stakeholder management and team coordination skills.
Excellent written and verbal communication skills in English.
Hands-on experience reviewing technical documents from QA, QC, PD, ARD, Production, and CROs.
Ability to interpret complex regulatory requirements and provide actionable guidance.
Proactive, self-motivated, and capable of working independently or in a team environment.
Why Join Amneal
Opportunity to work on complex injectable and ophthalmic-otic products for regulated global markets.
Collaborate with cross-functional global teams and gain exposure to US, EU, and Canadian regulatory frameworks.
Drive regulatory strategy and submissions for innovative pharmaceutical products.
Competitive compensation and growth opportunities in a fast-paced, scientifically driven environment.
Inclusive and diverse workplace culture that encourages learning, innovation, and professional development.
Apply Now on thepharmadaily.com to join a global pharmaceutical leader and advance your career in regulatory affairs for injectable products in the US and international markets.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
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Croatia |Zagreb :
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