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
solaya_sinha@intaspharma.com
