Deputy Manager, Regulatory Affairs – Injectable (US Market)
Location: Ahmedabad, Gujarat, India
Job Type: Full-Time | Regulatory Affairs
Job ID: 6715
Application Deadline: 30/01/2026
About Amneal
Amneal Pharmaceuticals is a global, patient-focused company delivering high-quality medicines across diverse therapeutic areas. We foster an inclusive, innovative, and collaborative work culture that empowers employees to grow professionally while ensuring regulatory excellence and patient safety.
Role Overview
Amneal is seeking a Deputy Manager – Regulatory Affairs specializing in Injectable and Ophthalmic-Otic dosage forms for the US market. The role focuses on regulatory CMC (Chemistry, Manufacturing, and Controls) submissions, ensuring compliance with FDA, EMA, and Health Canada regulations, and driving timely approvals of complex injectable products.
Key Responsibilities
Lead regulatory CMC activities for complex Injectable and Ophthalmic-Otic products, including ANDAs, MAAs, ANDS, and 505(b)(2) submissions.
Compile, review, and maintain dossiers and regulatory documentation, including technical documents from PD, ARD, QA, QC, Production, and CRO partners.
Prepare and review meeting packages, amendments, query responses, and controlled correspondences.
Develop regulatory strategies and white papers for general and complex injectable products.
Conduct primary review of DMFs for APIs and coordinate with procurement teams for vendor documentation.
Collaborate with cross-functional teams (R&D, ARD, QC, QA, Clinical, Labeling) to complete technical and regulatory tasks.
Monitor changes in regulations, procedures, and guidance, evaluating their impact on the product lifecycle.
Ensure timely and compliant submissions to US, EU, and Canadian health authorities.
Qualifications & Experience
Master’s degree in Pharmacy, Life Sciences, or a related field.
Hands-on experience with Parenteral dosage forms and complex injectables.
Proven experience in US, Europe, and Canada regulatory submissions.
Expertise in ANDA/NDA compilation, amendments, and regulatory correspondence.
Strong knowledge of regulatory CMC requirements, documentation standards, and lifecycle management.
Excellent communication, coordination, and organizational skills.
Why Join Amneal
Work on complex regulatory projects for injectable and specialty dosage forms.
Collaborate with global teams and enhance your regulatory expertise.
Be part of an inclusive, innovative, and growth-oriented environment focused on patient safety.
Location: Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat, 380015, India
Job Schedule: Full-time
Category: Regulatory Affairs | Master’s Degree Preferred
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Bangkok |Israel :
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McFarland | Green Way | Springville | Nairobi | Remote - South America (Latin Americal) | French | Melbourne | Remote, USA | Zaragoza | Medan | Lenexa | Switzerland | Remote - Africa | Bountiful | Remote | Castlebar | Leinster | Bishop | Lousiana | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Texas | Riga | Faridabad | Remote - Europe | Belgium | Tulsa | Minnesota | Ireland | Remote - Middle East | Hammond | Manipal | Slovakia | Victoria | Blue Bell | Xzagreb |Republic of Colombia :
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Rabigh | Jeddah | King Abdullah Economic City | Khulais | Najran | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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