Job detail for the post of Regulatory Affairs Specialist in Dr. Reddys Laboratories Ltd.. Hyderabad / Secunderabad, 2 to 6 years of experience. Apply for the job Now ! Search Jobs in India by Functional Area, Industry and Location. Search Jobs in India - Delhi, Mumbai, Bangalore, Kolkata. Find career openings in top companies. Post your resume and find your dream job Now !.
Experience:
2 - 6 Years
Location: Hyderabad / Secunderabad
Education: UG - B.Pharma - Pharmacy PG - M.Pharma - Pharmacy
Industry Type: Pharma/ Biotech/Clinical Research
Role: Regulatory Affairs Mgr
Functional Area: Healthcare, Medical, R&D
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
Keywords: Regulatory affairs, CTD, eCTD, Dossier Formulations
Desired 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).
Company Profile
Dr. Reddy's is one of the leading Generic Drug maker in the world and is in the area of Branded and Unbranded Generics pharmaceuticals and API.
IPDO (Integrated Product Development Organisation) is a world class Research and Development facility .It houses scientific talent across functions and has a deep culture of innovation This is one of its kind of facility in India ,which incorporates end to end (API to Formulation) integrated Research and Development
Contact Details
Company Name: Dr. Reddys Laboratories Ltd..
Executive Name: Joseph Ajay