torrent PHARMA
We are HIRING Join Our Team
Job Location: R&D Centre (Gandhinagar, Gujarat)
POSITION: ASSISTANT MANAGER
Department Regulatory Affairs Department
Qualification : MSc /M PHARM
RELEVANT EXPERIENCE : 08 to 12 Years
Market: ROW/Clinical
•BE NOC/Bio TI Export application
BE report review/e-CTD submission activity for Global markets
Having good understanding on Module 2 and Module 5 (clinical part) submission/query response activity for USFDA/EUROPE/BRAZIL/ROW markets.
BE study extension activity for ROW markets
Market: Domestic
Application for BE/CT/ММА (CT-5, CT-4, CT-21) and Import & Marketing application (CT-18, Form-40, Form-8) to DCGI as per NDCT rules, 2019 in Sugam portal.
Submission of query response and follow up for new product approvals.
Ensure the on-time filing of high-quality regulatory submission, and to assist in the preparation, maintenance, and control of regulatory dossiers.
• Interact with Regulatory agency on regulatory submissions and follow up for drug product approvals.
Market: EU Market - Pre and Post Approval
• Formulation Regulatory experience of various dosage form like Solid oral/Topical/Solutions/Suspension/Injectable /Ophthalmic/Peptide.
EU dessier compilation especially for Module 1, 2 & 3
Seasoned experience in handling of various EU procedure like DCP, MRP, National
National phase handling for EU procedures.
Post approval variation compilation and filling to various EU agencies
• Experience of eCTD compilation would be added advantage
Interested candidates may share their CVs on devalmodi@torrentpharma.com