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:





✔ Robust 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]

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📌 Sr Executive / Asst. Manager - Scientific review (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad