Work as Regulatory Affairs Executive in Epsilon Pharmaceuticals

Incorporated in November 1998, Epsilon Pharmaceuticals Private Limited is located at Jedcherla SEZ, near Hyderabad, Andhra Pradesh. With the advantage of location and a team comprising of experienced scientists and qualified professionals, Epsilon has robust infrastructure and broad technological strengths, capable of manufacturing a wide range of steriles in Oncology segment and also prescription drugs for its clients on contract basis.
As part of the company’s strategy to also formulate new molecules, a continuous process of research and development is undertaken at Epsilon by scientists. Parallely, Epsilon Pharmaceuticals is also forging alliances with multi-nationals in Europe, Latin America, African countries who have evinced keen interest in the company.

Post: Executive - Regulatory Affairs

Job Description:
• ANDA Submission for US Markets is required
• EU and ROW is an added advantage
• Dossier Compilation and Filings
• Patent Reviews
• CTD / e-CTD exposure is required
• Should know about US-FDA & MHRA requirements
• Injectables experience preferred
• Oncology experience preferred
• Variation Filing / Para - IV filing
• Regulatory follow-ups with agencies
• Knowledge and experience on ICH / EME /EUDRALEX Regulations
• Supplements, Annual updates SPL preparations.
• Ablity to have Plant documentation.

Candidate Profile:
Must be qualified in B. Pharma / M. Pharma / MSC
Relevant Experience - 5 - 10 years

Additional Information
Experience: 5-10 Years
Location: Hyderabad
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Compensation: 2.25-4.75 lakhs
End Date: 18th Jan, 2012