We’re Hiring | Clinical / Regulatory Affairs – ANDA & BE Studies We are looking for a scientifically strong professional 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 ✔ Robust 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
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📌 Sr Executive (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad