Regulatory Affairs Specialist Dr. Reddys Laboratories Ltd..

By: Pharma Jobs | Views: 5688 | Date: 14-Sep-2011

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 !.

Dr.Reddys Logo
 
 
 
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

Posted Date:

14 Sep

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

Address:

Not Mentioned

Email Address:

tatipdo@drreddys.com

Telephone:

04044346576

Reference ID:

RA2-6

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