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Torrent Pharmaceuticals requires Research Associate - Regulatory Affairs

By: Mitul Shah | Views: 3451 | Date: 06-Jul-2010

Candidate should be M.Pharma with 5-10 years of experience.

Torrent Pharma owes its success in the domestic market to its thrust on frontline research, strategic marketing and world-class manufacturing. It is among the largest spenders on R&D and has set up one of the most advanced research centers in the country at an investment of Rs. 200 crores so far. It has discovered and patented the AGE (Advanced Glycosylation End Product) Breaker Compound which has potential to treat heart diseases and diabetes related vascular complications. Its manufacturing facilities have received quality certifications from various international regulatory authorities.
Post: Research Associate-Regulatory Affairs (ROW markets)

Job Description:
# Planning, prioritizing and allocating the projects to subordinates.
# Reviewing and submission of dossiers.
# Reviewing technology transfer documents like STPs, method validation protocol and report, raw material specification, packaging material specification, finished product specification, stability protocol and MPDs.
# Reviewing manufacturing documents like MFC, MPD, BMR, BPR, process validation protocol/report, stability protocol/report, sampling protocol, process validation protocol and product development report.
# Ensuring the evaluation of queries raised by Regulatory Authority and reviewing the response made by subordinates.
# Reviewing Technology Transfer documents for commercial batches and export order authorization.
# Finalizing re-registration dossiers.
# Monitoring assessment and initiation of change control form and deviation form.

Candidate profile:
Candidate should be M.Pharma with 5-10 years of experience.

Additional Information:
Experience: 5-10 years
Location: Ahmedabad
Education: M.Pharm
Industry Type: Pharma/Healthcare/Clinical research
Functional Area: Regulatory Affairs
To Apply online, CLICK HERE

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