Senior Executive – Regulatory Affairs (US Injectable, Pre-Approval)
Location: Ahmedabad, Gujarat, India
Job Type: Full-Time | Regulatory Affairs
Job ID: 6500
Application Deadline: 30/01/2026
About Amneal
Amneal Pharmaceuticals is a leading global pharmaceutical company dedicated to delivering high-quality medicines across multiple therapeutic areas. With a focus on innovation, compliance, and patient safety, Amneal fosters a collaborative work environment that encourages professional growth and regulatory excellence.
Role Overview
Amneal is seeking a Senior Executive – Regulatory Affairs with expertise in US injectable and sterile dosage forms. This role focuses on the pre-approval phase, including preparation, review, and submission of ANDAs, NDAs, and amendments to the FDA. The position ensures timely submissions, regulatory compliance, and strategic management of pre-approval projects.
Key Responsibilities
Compile, prepare, review, and submit ANDA submissions, amendments, and controlled correspondences to FDA for injectable, ophthalmic, and otic products.
Ensure submissions meet FDA requirements and minimize queries, rejections, or delays.
Evaluate change controls, formulate filing strategies, and proactively address regulatory issues.
Prepare Pre-ANDA, Pre-IND, and Pre-NDA meeting packages and respond to FDA deficiency letters with strategic solutions.
Review API DMFs and coordinate with purchase teams or DMF holders to ensure compliance.
Collaborate with R&D, QA, QC, ARD, Clinical, and Labeling teams to ensure timely availability of documents for submission.
Maintain archival and lifecycle management of all regulatory submissions.
Stay updated on ICH, FDA, and 21 CFR regulations, and ensure adherence to SOPs and regulatory standards.
Perform technical writing for regulatory documents and contribute to regulatory strategy development.
Support cross-functional teams in problem-solving, risk mitigation, and change management.
Required Skills
Regulatory submission & dossier filing | Advanced
CMC documentation | Advanced
Regulatory strategy development | Advanced
Health authority query response | Advanced
Product lifecycle management | Advanced
Change control & regulatory impact assessment | Advanced
Cross-functional communication | Intermediate
Problem-solving & risk mitigation | Intermediate
Qualifications & Experience
M. Pharm or equivalent degree.
Hands-on experience with US Injectable, Ophthalmic, Otic, and IV Bag dosage forms.
Proven experience in ANDA, NDA, and Pre-approval submissions.
Strong knowledge of FDA regulations, ICH guidelines, and US submission requirements.
Excellent technical writing, time management, and organizational skills.
Ability to work independently, prioritize tasks, and collaborate with global teams.
Why Join Amneal
Lead regulatory pre-approval projects for complex injectable products.
Collaborate with cross-functional teams in a dynamic, global pharmaceutical environment.
Opportunity to gain hands-on experience with US FDA submissions and regulatory strategy.
Be part of an inclusive organization that values growth, compliance, and innovation.
Location: Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat, 380015, India
Job Schedule: Full-Time
Category: Regulatory Affairs | M. Pharm
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