Tuesday, August 22, 2023

Openings at Intas Pharmaceuticals

We at Intas Pharmaceuticals (Biopharma Division) are currently hiring for below role:
Assistant Manager/Manager/Senior Manager - Regulatory Affairs with 6+ years of experience.

Job Responsibilities:

1) Ensure preparation, review and submission of CTD sections in compliance with requirements of EMA, USFDA and other global markets.
2) Timely update and preparation of dossier and documents as well as responses to the queries raised by regulatory agencies.
3) Registration application preparation including administrative documents and GMP audit support for global markets
4) Publishing of drug registration applications and lifecycle management submissions.
5) Preparation of gap analysis for the registration in regulated and semi regulated markets.
6) Assist in establishing and tracking effective change control management coming for regulatory review and approval.
7) Actively participate in Regulatory Information management system assessment, and implementation.
8) To review CMC documents for its compliance and adequacy of information for regulated market filing.
9) Review and assessment of change controls and related variation submissions to global markets.

Qualifications Required:
Bachelors/Masters in the field of Biotechnology/Biological Sciences/Pharmacy/Regulatory Affairs

Interested candidates can share their CVs on

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