We’re Hiring | Clinical / Regulatory Affairs – ANDA & BE Studies

We are looking for a scientifically strong qualified to join our team and contribute to clinical study planning, protocol review and regulatory submissions.

Key Responsibilities:
• Evaluate feasibility of new molecules through literature research
• Design study synopses for pilot and pivotal studies
• Review clinical study protocols as per USFDA, ICH and local regulatory requirements
• Coordinate with internal teams and CROs for timely protocol finalization
• Scientifically review Clinical Study Reports (CSR) in line with protocol, USFDA and ICH E3 requirements
• Support ANDA-related regulatory activities
• Monitor BE studies, as required
• Manage multiple priorities, including time-sensitive filing projects

What we’re looking for:




✔ Strong knowledge of USFDA regulations and ANDA submissions
✔ Good understanding of BE studies and clinical research
✔ Strong scientific and analytical skills
✔ Good written and verbal communication skills
✔ Ability to work effectively under pressure and meet critical timelines

Location: Ahmedabad
Experience: [Years of Experience]

If you are interested or know someone who could be a good fit, share your profile at [email protected] with a cc to [email protected]
Hiring #PharmaJobs #ClinicalResearch #RegulatoryAffairs #ANDA #Bioequivalence #USFDA #PharmaHiring #LifeSciences #Careers

📌 Sr Executive (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad