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13 July 2010

Dr Reddy’s Hyderabad Pharmacy Regulatory Affairs Scientist Jobs


Dr Reddys Laboratories Ltd

7-1-27 Ameerpet


Regulatory Affairs

Experience: 1 - 6 Years

Location: Hyderabad / Secunderabad

Compensation: Rupees 2,00,000 - 7,00,000


UG - B.Pharma - Pharmacy PG - M.Pharma - Pharmacy

Role: Research Scientist

Desired Candidate Profile

M.Pham with 1-6 years of experience in Regulatory affairs for US,EU,RoW Regions

Job Description

Providing regulatory guidance throughout R&D and mfg processes.

Compiling / Writing & submitting regulatory documents in an efficient and timely manner.

Integrate the relevant regulatory policies, guidance’s and procedural requirements into the developmental phase of the multi functional teams.

Follow-up on submissions to ensure final approval in the shortest possible time.

Auditing at various phases of development to ensure regulatory compliance.

Responsible for responding to any regulatory queries on behalf of the project team with inputs from other team members.

Anticipate issues from a reviewer perspective and proactively ensure actions.

Ensure project work is auditable, complete & error free

License applications-Test license, BE NOC, CT NOC, M&M application, Mfg license etc.

Ensuring availability of documents like WHO GMP Certificates

Interaction with RA counterpart of bulk suppliers.

Develop/Review of SOP's, Checklists

Company Profile

Integrated Product Development Organization (IPDO) is one of the key growth driver of Dr. Reddy’s. This BU integrates all the R&D functions of API, Formulation (Branded) & Generics to create synergy, crash timelines and enhance capability in developing medicines. Essentially there are three types of teams, Product Development Teams (in API, Branded Formulations & Generics), Capability Enhancement Teams (Centers of Excellence - COEs) & Common Resource Teams (CRTs).

Product Development Teams develops new products for different market using project management approach. Capability Enhancement Teams creates technical capabilities to keep the organization ahead of competition.

With project management driven product development and capabilities created ahead of competition, IPDO is raring to achieve targets that will catapult Dr Reddy’s to a new league of players, the new Indian multinationals.

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