Dr. Reddy's Laboratories Needs Regulatory Affairs Specialist

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.

Post: Regulatory Affairs Specialist

Job Description:
Compiling / Writing & submitting regulatory documents in an efficient and timely manner.
License applications-Test license, BE NOC, CT NOC, M&M application,Mfg license etc.
Preparation of ANDAs, NDAs
Review/preparation of amendments and supplements for deficiencies, if any
Review/ preparation of annual reports
Application of various licenses.
Participating in project meetings
Production of ANDAs

Candidate Profile:
Work with Regulatory Agency(ies)/Consultants to derive/endorse key regulatory/clinical strategy(ies) – During R&D, pre- dossier submission, post-dossier submission
Review, compilation and submission of dossiers.
Collaborate and drive regulatory approvals with the local (India) and international regulatory body(ies).

Additional Information:
Experience: 2-6 Years
Education: B.Pharm, M.Pharm
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Last Date: 30^th Sept., 2011