Are you a B.Pharm, M.Pharm, or M.Sc graduate with 3-8 years of experience in Regulatory Affairs? Eugia Pharma is hiring skilled professionals for its Regulatory Affairs team in Hyderabad. If you have expertise in CMC, Post-Approval, or Labeling for US/EU/Canada & Emerging Markets, this could be your next career move!
📩 Send your CV to: Shaher.Banu@eugiapharma.com
📍 Location: Pashamylaram, Hyderabad
Job Description (Regulatory Affairs Associate/Senior Associate)
Key Responsibilities:
- Prepare, review, and submit regulatory filings (ANDAs, NDAs, DMFs, variations, renewals) for US, EU, Canada, and Emerging Markets.
- Handle CMC (Chemistry, Manufacturing, Controls) documentation for regulatory submissions.
- Manage post-approval changes, including supplements, amendments, and annual reports.
- Ensure compliance with ICH, FDA, EMA, and other global regulatory guidelines.
- Review and approve product labeling (PI, SmPC, artwork) as per regulatory requirements.
- Coordinate with cross-functional teams (R&D, QA, QC) for timely submissions.
- Stay updated with evolving regulatory trends and guidelines.
Desired Qualifications & Experience:
- B.Pharm / M.Pharm / M.Sc in Life Sciences or related field.
- 3-8 years of hands-on experience in Regulatory Affairs (CMC/Post-Approval/Labeling).
- Strong knowledge of eCTD submissions, CTD format, and regulatory databases.
- Experience in US, EU, Canada, or Emerging Markets is a plus.
- Excellent communication and documentation skills.
About Eugia Pharma
Eugia Pharma is a leading pharmaceutical company specializing in sterile injectables, oncology, and general medicines. With a strong presence in global markets, Eugia is committed to delivering high-quality, affordable healthcare solutions.
🔹 Why Join Eugia?
- Work with a dynamic and growing pharma company.
- Opportunities for career growth and skill development.
- Be part of a collaborative and innovative team.
How to Apply?
If you meet the eligibility criteria, send your updated CV/Resume to:
📧 Email: Shaher.Banu@eugiapharma.com
