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  • Regulatory Affairs Asst/ dept Manager - Pharma API - Nashik

    1. 10 - 15 yrs
    2. Mumbai
    Rs 8,00,000 to 10,00,000 p.a.

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  • Job View 427 Views
  • Applicants Less than 5 Applicants

Job Description

Review and Submission of Drug Master File (DMFs) for US, EU & Japan, Submission of Certificate of Suitability (CEPs) dossier for EDQM, DMFs for Health Canada and Updates.

Handling of deficiencies raised by FDA during the course of reviewing of the USDMFs as well as deficiencies raised by EUs during the course of reviewing of the EDMFs under Centralized (CP), Decentralized (DCPs), Mutual Recognition Procedures (MRP) and National Procedures.

To ensure the Regulatory Compliance across the manufacturing site.

Review of Change Controls for their impact on the respective Regulatory submissions.

Interaction with Global customers regarding various Regulatory issues related to submission of Applicants Part of Active Substance Master Files [ASMFs] Under MAA.

Evaluation of starting materials for their adequacy with respect to Regulatory submission.

Handling of Questionnaires of various customers & regulatory authorities.

Review and evaluation of Stability Data for Regulatory Submissions.

Preparation and review of SOPs related to Regulatory Affairs.

Additional Responsibility:

Handling of eCTD software and other e-Platform for submission of Regulatory Documents in various Regulatory Agencies.

Key Skills

Industry

Pharma/BioTech/Clinical Research

Functional Area

Legal / Law Services / Judiciary

Number of Vacancy

1

Education

M.Pharma


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