Analyst - Global Regulatory Affairs - Dr. Reddy's Laboratories Ltd.

By: Pharma Jobs | Views: 3389 | Date: 08-Feb-2015

Dr. Reddy's Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascul

Analyst - Global Regulatory Affairs - Dr. Reddy's Laboratories Ltd.

Dr. Reddy's Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets. For more information, log on to: www.drreddys.com





Designation Analyst - Global Regulatory Affairs - 2 Opening(s)
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.
Manage change controls and deviation controls.
Keep themselves abreast of international legislation, guidelines and customer practices
Develop and write clear arguments and explanations for new product licenses and license renewals.
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.
Desired Profile Please refer to the Job description above
Experience 3 - 7 Years
Industry Type Pharma / Biotech / Clinical Research
Role Research Scientist
Functional Area Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Education

UG - B.Pharma - Pharmacy

PG - M.Pharma - Pharmacy

Doctorate - Doctorate Not Required

Compensation:  Not disclosed
Location Hyderabad / Secunderabad
Keywords Regulatory Affairs Formulations Oral solids injectable
Contact Dr. Reddy's Recruitment Team
Dr Reddys Laboratories Ltd
8-2-337, Road No 3,
Banjara Hills
HYDERABAD,Andhra Pradesh,India 500034
Email sureshkm@drreddys.com
Website http://www.drreddys.com
Job Posted 2015-02-03 00:02:24.0

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