Intas is expanding and evolving its Biopharmaceutical capabilities. We invite ambitious professionals to be a part of its future growth story. Interested & eligible Candidates are requested to click the link to apply for Manufacturing position.
Post : Sr. Executive/ Asst. Manager/ Manager - Regulatory Affairs
Job Description
Purpose of Job
Accountable for preparation of submissions to regulated markets for licenses/approvals and coordinating with all cross-functional teams for regulatory filings.
Roles and Responsibilities
Ensure preparation, review and submission of CTD sections in compliance with requirements of EMA, USFDA and other global markets.
Timely update and preparation of dossier and documents as well as responses to the queries raised by regulatory agencies
Registration application preparation including administrative documents and GMP audit support for global markets
Publishing of drug registration applications and lifecycle management submissions
Preparation of gap analysis for the registration in regulated and semi regulated markets.
Assist in establishing and tracking effective change control management coming for regulatory review and approval.
Actively participate in Regulatory Information management system assessment, and implementation.
To review CMC documents for its compliance and adequacy of information for regulated market filing.
Review and assessment of change controls and related variation submissions to global markets
Candidate Profile
• Bachelor/Masters in the field of Biotechnology/Biological sciences/Pharmacy/Regulator Affairs RAC certification will be an added advantage
• Relevant experience in CMC writing, eCTD publishing and regulatory operations
• 6-8 years of work experience in Regulatory Affairs for Biosimilars/biologics for global markets
• Should be ready to relocate to Ahmedabad as WFH option is not available
Job Location : Ahmedabad, Biopharma Plant
Date : 20th October 2024 (Sunday)
Time : 09:00 am to 06:00 pm
Mode : Virtual - MS Teams
• The shortlisted candidates will be shared MS teams link for interview discussion.
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