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Dr. Reddy's Laboratories Ltd. Opening in March 2013

By: JobSearch | Views: 2441 | Date: 10-Mar-2013

Regulatory Affairs - India (senior Analyst) , Dr.reddy's by Dr. Reddy's Laboratories Ltd. in Hyderabad / Secunderabad,Experience: 8 to 10 yrs.


Dr. Reddys' logo

Regulatory Affairs - India (senior Analyst) , Dr.reddy's

by Dr. Reddy's Laboratories Ltd. in Hyderabad / Secunderabad

Experience: 8 to 10 yrs.  

Opening(s): 1

Posted on: 10 Mar

Job Description:
Key Responsibilities:

- Responsible for preparation applications for obtaining Manufacturing licences, BE-NoC, CT-NoC, WHO GMP, CoPP

across all dosage forms & API

manufacturing locations

- Responsible for the maintenance of import licences for developmental purpose

- Responsible for review of Plant related documents (MFR, PVP,PVR, Stability protocols, Specifications)

Job Requirements

Technical Requirements:

- Understanding of various dosage forms, their development and bulk active manufacturing

- Knowledge of Manufacturing work orders, PVP, PVR, Stability protocols

- Hands on experience of current GMP/GLP requirements and their compliance

- Knowledge of change control management

Key Attributes:

- Excellent planning & organizing skills with attention

- Good people development skills including ability to learn & understand the regulatory guidelines

- Consistent focus on performance, project goals and outcomes

- Collaborative skills

Operating Network:

Internal: Product Development Teams, GG-India marketing teams, Corporate Legal, Plant QA personnel, Corporate Affairs,

FTMR, RA (Other regions), LL QA, Contract Mfg Team, SCM

External: DCG(I), State DCA & Narcotics Department

Educational Qualifications: Masters in Pharmaceutics/Chemistry with about of 7-8 years experience in the Pharmaceutical

Industry preferred.

Experience Required: 8 years experience in manufacturing operations.

Salary:

Not Disclosed by Recruiter

Industry:

Pharma / Biotech / Clinical Research

Functional Area:

Legal, Regulatory, Intellectual Property

Role Category:

Drug Regulatory Affairs/Documentation

Role:

Regulatory Affairs Manager

Keyskills:

Regulatory Affairs, cmc documentation, regulatory compliance, registration, ctd

Desired Candidate Profile
Education:

(UG - B.Sc - Any Specialization, Chemistry, B.Pharma - Pharmacy) AND (PG - M.Sc - Any Specialization, Chemistry, M.Pharma - Pharmacy) AND ( Doctorate - Ph.D - Advertising/Mass Communication, Chemistry, Pharmacy)

Please refer to the Job description above
Company Profile
Dr. Reddy's Laboratories Ltd. 
http://www.drreddys.com
Dr Reddy's is a global, vertically integrated pharmaceutical company with a presence across the value chain, producing and delivering safe, innovative, and high quality finished dosage forms, active pharmaceutical ingredients and biological products. Our products are marketed across the globe, with an emphasis on North America, Europe, India, Russia and other emerging markets. We conduct NCE drug discovery research in the areas of metabolic disorders and cardiovascular indications at our research facilities in Atlanta (USA) and Hyderabad (India). Through our Custom Pharmaceutical Services business unit, we provide drug substance and drug product development and manufacturing services on a proprietary basis.
Contact Details
Recruiter Name:

Ajitabh Sinha

Contact Company:

Dr Reddys Laboratories Ltd

Address:

Ankur, Plot No. 187-A, Road No. 13, Jubilee Hills HYDERABAD,Andhra Pradesh,India

Telephone:

91-40-44346576

Reference Id:

D - 3202 - 1

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