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Post for a Manager - Regulatory Affairs in Zydus Cadila




Clinical research courses

Zydus Cadila is a professionally managed public company offering immense opportunities to learn and grow. This ability to evolve, gain new capabilities and raise the bar of excellence forms the heart of our success. We provide an environment where people come and give their best not because they have to, but because they want to. At Zydus we build people to build our business.
If you have the talent and zeal to achieve the best, Zydus will provide you the opportunity. A conducive and vibrant work culture, opportunities to learn and grow.

Post: Manager - Regulatory Affairs

Job Description:
1. Responsible for reviewing the regulatory submission and technical documents sent to various Regulatory Authorities and customer.
2. Data compilation and filing of DMFs for various regulatory authorities in USFDA in Europe, to EDQM, to TPD-Canada, to TGA-Australia in accordance to the filing requirements of Regulatory Authorities and periodic updating of USMFs (Annual Updates) and Canadian DMFs (Bi-Annual Updates).
3. Data compiling of different kinds of Amendments (scale up, scale up along with process changes) to both EDQM and USFDA for the submitted DMFs.
4. Analyzing the data that is received from both plant QA and R&D (data review) and correlated with the submitted information, compile the DMF/responding the deficiencies in accordance with the regulations.
5. Review of change control procedure with respect to their impact in Regulatory Submission.

Candidate Profile:
Qualification & Experience – M.Sc or Ph.D in Organic Chemistry having 5-10 years of experience in Regulatory Affairs.

Additional Information:
5-10 Years
Education: M.Sc-Chemistry, Ph.D-Organic Chemistry
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 26th Sept, 2011

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