Senior Executive – Regulatory Affairs (US ANDA | Post-Approval | CTD Submissions)
Location: India (Ahmedabad, Gujarat and additional location)
Department: Regulatory Affairs
Job Type: Full-Time
Job ID: 7034
Application Deadline: 28 February 2026
Qualification Required: Master’s Degree (M.Pharm or equivalent)
Company: Amneal Pharmaceuticals
Role Overview
Amneal Pharmaceuticals is seeking a Senior Executive – Regulatory Affairs to support U.S. ANDA submissions, post-approval regulatory activities, and CTD documentation management. This position plays a critical role in ensuring timely, compliant, and high-quality submissions aligned with US FDA and ICH regulatory guidelines.
The ideal candidate will have hands-on experience in ANDA lifecycle management, Annual Reports, CBE-0, CBE-30, PAS filings, API DMF review, and cross-functional regulatory coordination. This role is suited for regulatory professionals experienced in oral solid dosage forms, sterile, complex, or topical/inhalation products within the generic pharmaceutical sector.
Key Responsibilities
ANDA Submission & Post-Approval Management
Support ANDA submission activities in accordance with US FDA and ICH guidelines.
Manage post-approval regulatory procedures including Annual Reports, CBE-0, CBE-30, and Prior Approval Supplements (PAS).
Draft Annual Reports with required submission data per FDA guidance.
Ensure accurate and timely drafting, compilation, and submission of regulatory documents.
CTD Dossier Preparation & Review
Draft and conduct preliminary review of CTD Modules for ANDA submissions.
Perform preliminary review of complete submission packages prior to filing.
Maintain regulatory documentation and submission archives systematically.
API & CMC Regulatory Oversight
Review API DMFs in compliance with US FDA requirements.
Evaluate change control cases in alignment with ICH quality guidelines and US FDA post-approval guidance.
Assess regulatory impact and determine appropriate filing categories.
Regulatory Communication & FDA Interaction
Draft Controlled Correspondence and Briefing Packages for FDA communications.
Ensure awareness of FDA requirements related to commercial marketing status notification submissions.
Maintain understanding of regulatory timelines and content expectations for US filings.
Cross-Functional Coordination
Coordinate with R&D, Quality, Manufacturing, and Supply Chain teams to ensure timely document availability.
Align submission plans with regulatory timelines to avoid delays.
Proactively address potential compliance gaps prior to submission.
Required Experience
4 to 7 years of experience in US Regulatory Affairs within the pharmaceutical industry.
Practical exposure to ANDA submissions and post-approval procedures.
Experience handling Annual Reports, CBE-0, CBE-30, and PAS filings.
Hands-on knowledge of API DMF review and CMC documentation.
Experience with Solid Oral Dosage Forms, Sterile dosage forms, Complex products, or Topical/Inhalation products.
Strong understanding of ICH guidelines, US FDA regulations, and post-approval submission pathways.
Educational Qualification
Master’s Degree in Pharmacy (M.Pharm) or equivalent.
Core Competencies
Advanced knowledge of ANDA submission strategy and lifecycle management.
Strong expertise in CTD dossier drafting and regulatory documentation.
Good understanding of US FDA regulatory framework and 21 CFR compliance.
Strong analytical and problem-solving skills.
Effective technical writing and communication skills.
Ability to manage multiple submissions under strict timelines.
Proficiency in Microsoft Office tools and regulatory documentation systems.
Why Join Amneal Pharmaceuticals
Amneal Pharmaceuticals is a global pharmaceutical company dedicated to delivering affordable, high-quality medicines. With strong expertise in generics and specialty pharmaceuticals, Amneal provides regulatory professionals the opportunity to work on complex ANDA strategies and US market submissions.
The organization fosters an inclusive, collaborative, and performance-driven environment focused on regulatory excellence and continuous professional growth.
Equal Opportunity Statement
Amneal Pharmaceuticals is an equal opportunity employer committed to diversity and inclusion in the workplace.
Apply now through ThePharmaDaily.com to advance your career in US Regulatory Affairs, ANDA lifecycle management, and global pharmaceutical compliance.
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