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
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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.
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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
Apply / Forward Your Resume at, hr@epsilonpharma.net
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