About Intas Pharma: Intas Pharma is expanding its biopharmaceutical capabilities and invites ambitious professionals to contribute to its growth story. We are seeking qualified candidates for our Regulatory Affairs team to support our mission of delivering high-quality biopharmaceutical products.
Job Description:
Purpose of the Job:
You will be responsible for the preparation and submission of regulatory filings for licenses and approvals in regulated markets, collaborating with cross-functional teams.
Key Responsibilities:
- Prepare, review, and submit CTD sections in compliance with EMA, USFDA, and other global market requirements.
- Timely update and prepare dossiers and documents, including responses to regulatory agency queries.
- Handle registration application preparation, including administrative documents and GMP audit support.
- Publish drug registration applications and manage lifecycle submissions.
- Conduct gap analysis for registrations in regulated and semi-regulated markets.
- Establish and track effective change control management for regulatory review and approval.
- Participate in the assessment and implementation of the Regulatory Information Management System.
- Review CMC documents for compliance and adequacy for regulated market filings.
- Assess change controls and related variation submissions for global markets.
Candidate Profile:
- M.Pharm, MSc in Biotechnology/Biological Sciences/Pharmacy/Regulatory Affairs.
- RAC certification is an added advantage.
- 6-8 years of relevant experience in CMC writing, eCTD publishing, and regulatory operations, specifically for Biosimilars/Biologics.
- Willing to relocate to Ahmedabad; WFH options are not available.
How to Apply: Interested candidates are invited to apply by clicking the link provided in the job announcement.
Walk In Interview
Position: Senior Executive/Assistant Manager/Manager – Regulatory Affairs
Location: Ahmedabad, Biopharma Plant
Application Deadline: 20th October 2024
Interview Date: 20th October 2024 (Virtual via MS Teams)
Time: 09:00 AM to 06:00 PM