Deputy Manager – Regulatory Affairs (Complex Products | US & EU Markets)
Location: Ahmedabad, Gujarat, India
Employment Type: Full-Time
Function: Regulatory Affairs – Complex & Specialty Products
Job ID: 7089
Application Deadline: 28 February 2026
Job Overview
We are seeking an accomplished Deputy Manager – Regulatory Affairs with deep expertise in complex pharmaceutical products to lead regulatory strategy, submissions, and health authority interactions for US and European markets. This role is critical in managing regulatory pathways for injectables and advanced drug delivery systems, ensuring compliance, quality, and timely approvals across the product lifecycle.
This position is ideal for senior regulatory professionals with hands-on experience in 505(b)(2) pathways, complex dosage forms, and cross-functional collaboration within a global pharmaceutical environment.
Key Responsibilities
Regulatory Strategy & Global Submissions
Develop, review, and finalize regulatory strategies for complex products, including injectables (peptides, microspheres, liposomes, nanosuspensions), ophthalmic, otic, topical gels, drug-device combination products (DDCP), and 505(b)(2) programs for the US and EU markets.
Lead the preparation, review, and finalization of Pre-ANDA, Pre-IND, and Scientific Advice (ScA) meeting packages for global health authorities.
Draft and finalize controlled correspondences addressing complex scientific and regulatory topics.
Health Authority Interactions & Deficiency Management
Review, finalize, and submit deficiency responses for complex and 505(b)(2) products to US FDA and EU regulatory agencies.
Support regulatory negotiations by providing scientifically sound, compliant, and risk-based regulatory positions.
Technical & CMC Review
Review API and Finished Product in-vitro characterization and sameness reports for complex dosage forms.
Perform Drug Master File (DMF) reviews for complex APIs in alignment with internal workflows and regulatory expectations.
Cross-Functional Leadership & Governance
Collaborate closely with CMC, R&D, Analytical Development, Quality, Clinical, and Project Management teams to ensure aligned regulatory execution.
Meet management expectations related to submission timelines, quality standards, and regulatory compliance.
Provide training and mentorship to team members on evolving regulatory requirements for complex products and advanced delivery systems.
Education & Qualifications
Master’s degree in Pharmacy (M. Pharm) or PhD is required.
Specialization in Regulatory Affairs or Pharmaceutics is strongly preferred.
Experience Requirements
Minimum 8–10 years of direct Regulatory Affairs experience in injectable and complex dosage forms.
Overall industry experience of 12+ years within pharmaceutical product development and regulatory functions.
Proven end-to-end regulatory experience covering strategy development, filings, deficiency responses, and approvals for US and EU markets.
Core Skills & Competencies
In-depth knowledge of US FDA and EU regulatory frameworks for complex products.
Expertise in 505(b)(2) submissions, controlled correspondence drafting, and regulatory meeting management.
Strong scientific judgment, critical thinking, and compliance-focused decision-making.
Experience working in matrix organizations and cross-functional global teams.
High standards of integrity, accountability, and ownership with a quality-driven mindset.
Strong communication, stakeholder management, and mentoring capabilities.
About the Company
Amneal is an equal opportunity employer committed to fostering a diverse, inclusive, and high-performance workplace. We value scientific rigor, regulatory excellence, and collaboration in delivering high-quality medicines to patients worldwide.
Why This Role?
This position offers the opportunity to work on high-impact, complex pharmaceutical programs with exposure to global regulatory authorities, advanced drug delivery technologies, and strategic decision-making at a senior level.
Apply Now
Interested professionals are encouraged to apply through thepharmadaily.com to be considered for this senior Regulatory Affairs leadership opportunity.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Peru | Argentina |Brazil :
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Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
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Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
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