Vacancy as team member in Regulatory affairs at Dr. Reddy's Lab

Dr. Reddy's Lab

Work as Team Member-Regulatory Affairs

About Company,
Established in 1984, Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company with proven research capabilities. The company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.

Job Description:
• Participate in the regulatory activities of full spectrum of formulation development, from clinical trials to marketing to post approval activities.
• Ensure the appropriate licensing, marketing and legal compliance of the finished dosages.
• Review the documents at each stage of formulations development.
• Highlight the regulatory issues that can be there and try to resolve them.
• Coordinate with R&D, AR&D, QA, etc. to collect the complete set of documents.
• Compile the ANDA document to be submitted to FDA.
• Ensure the documents are error free and have minimum deficiencies.
• Prepare annual reports and send them to FDA.
• Advise PDTs on regulatory requirements.
• Respond to the queries of Regulatory authorities and customers on time.
• Review the process change proposals and provide guidance on change proposals.

Candidate Profile:
1. Required Education: M.Pharm
2. Minimum Experience: 1-2 years of experience in RA

Additional Information:
Experience: 1-2 years
Location: Hyderabad
Education: M.Pharm,
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory affairs
Unit: Integrated Product Development Organization
Job Expiry: Saturday, March 20, 2010

To Apply/Send your resume, CLICK HERE