• Sarthee Consultancy Company Logo

  • Regulatory Affairs API

    1. 3 - 8 yrs
    2. Mumbai
    Rs 2,50,000 to 6,00,000 p.a.

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  • Job View 334 Views
  • Applicants Less than 5 Applicants

Job Description

Preparation , review and timely submission of DMF (CTD / ACTD formats) as per plan.

2. Review of Technical documents received from various Site

3. Coordinating with R & D , QA , Production , ADL and Purchase for collection of Technical data for the compilation as per the guidelines

4. Co - ordination with marketing dept. , external , Regulatory Authorities communications.

5. Query handling & timely response to customers and regulatory Authorities

6. Preparation and filing of revisions / Amendments to various authorities.

7. Ready to travel to all manufacturing locations to arrange data for Regulatory filing

Key Skills

  • API


Pharma/BioTech/Clinical Research

Functional Area

Medical / Health Care / Hospitals

Number of Vacancy




About Sarthee Consultancy


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