Are you an experienced Regulatory Affairs professional with expertise in post-approval submissions and USFDA guidelines? Amneal Pharmaceuticals is hiring a Senior Executive – Regulatory Affairs (Post Approval) in Ahmedabad. If you have a strong background in ANDA submissions, regulatory compliance, and FDA filings, this could be your next big career move!
📌 Job Description
Key Responsibilities:
✔ ANDA Submission & Post-Approval Compliance: Good knowledge of ANDA submission activities, post-approval procedures, and related ICH & USFDA guidelines.
✔ API DMF Review: Evaluate API DMF concerning USFDA regulatory requirements.
✔ Dosage Form Expertise: Exposure to Solid Oral Dosage, Sterile Dosage, Complex Dosage, Topical & Inhalation Dosage Forms, including their manufacturing processes & key regulatory aspects.
✔ Change Control Assessment: Preliminary review of change cases as per ICH Quality Guidelines and USFDA post-approval guidance.
✔ Regulatory Submissions: Draft Annual Reports, CBE-0, CBE-30, and PAS filings in compliance with USFDA requirements.
✔ FDA Correspondence: Draft controlled correspondence & briefing packages for FDA submissions.
✔ Commercial Marketing Submissions: Awareness of FDA recommendations for commercial marketing status notifications.
✔ Cross-Functional Coordination: Work with R&D, Manufacturing, and QA teams to ensure timely document availability for regulatory submissions.
✔ Regulatory Documentation: Maintain accurate regulatory records and ensure no delays in submissions.
✔ CTD Module Drafting: Strong skills in drafting Regulatory CTD Modules.
🏆 About Amneal Pharmaceuticals
Amneal Pharmaceuticals is a global leader in generic and specialty pharmaceuticals, committed to delivering high-quality, affordable medicines. With a strong presence in the US and international markets, Amneal focuses on innovation, compliance, and patient-centric solutions.
Why Join Amneal?
✅ Equal Opportunity Employer – We promote diversity & inclusion.
✅ Growth-Oriented Work Culture – Opportunities for career advancement.
✅ Industry-Leading Expertise – Work on complex regulatory filings with a global impact.
