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Regulatory Affairs

Renee C

B.Sc, M.Pharm, M.Sc as Officer / Executive – Regulatory Affairs – API @ Sun Pharma

 Sun Pharma ranks amongst India’s largest pharma companies We’have  built a reputation for speciality therapy leadership and faster- than-industry growth over the last 30 years. From a modest beginning with five people, our team today exceeds 13,000 and growing, put manufacturing base now spans 25 sites across the world. With a market cap of over $ 16 billion, we’re also India’s most valued pharma brand. To keep pace with our growth plans, we require for our Formulation manufacturing plant at Halo! (Near Baroda):

 

Post: Officer / Executive – Regulatory Affairs – API

 

Job description
1. Preparation and Execution of Drug Master files of API in CTD and ECTD format, independently in coordination with plant people.
2. Checking and reviewing of documents required for DMF filing received from plant for its thoroughness and getting corrections done from plant, independently.
3. Handling to DMF deficiencies Preparation of action plan and deficiency responses Timely Response of DMF deficiencies in coordination from R&D, Plant , ADD
4. Annual updates of DMF and renewal applications for CEP .
5. Completion of QA and ISO questionnaire received from customers in coordination with plants.
6. Helping API plants for the preparation of audits from Regulatory Agencies, in case required.
7. Moving to API locations for checking and collection of documents as and when required.

 

Desired Skills and Experience


Qualification – Bsc, Msc, M. pharma

Experience – 4 to 9 years of experience in API Regulatory Affairs

Additional Information:

Qualification: Bsc, Msc, Mpharm

Experience: 4-9 Year

Industry Type: Pharma/Biotech/Clinical Research

Functional Area: DRA

End Date: 16th Nov, 2013

Apply through their website

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