Required Assistant Manager/Manager/Senior Manager - Regulatory Affairs

Pharma Vacancy
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


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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