Regulatory Affairs Manager

The person will be responsible for leading the Regulatory Affairs function for the company's Generic/OTC/NHP NHP product portfolio across Canada, USA and European regulated markets. The role will be responsible for developing and executing regulatory strategies, managing product registrations, ensuring regulatory compliance, and driving timely approvals from global health authorities. Expertise in regulatory strategy, agency interactions, handling queries, inspections, audits, and compliance

The candidate will report directly to the Vice President/CEO.

Job Location-
Noida, New Delhi

Skills & Qualifications

Education
- Bachelor's/Master’s degree in Pharmacy, Pharmaceutical Sciences or a related life science discipline is required.

Experience
- 10–15 years of progressive Regulatory Affairs experience within the pharmaceutical industry.




- Extensive experience with Generic products in regulated markets.
- Demonstrated experience in preparing and submitting ANDS, ANDA, NDA, eCTD submissions and post-approval regulatory filings.
- Robust understanding of ICH guidelines, GMP requirements, CTD/eCTD structure and global regulatory expectations.
- Proven experience managing Health Canada, US FDA, EMA/MHRA and other regulatory agency interactions.
- Experience in technology transfers, product licensing, acquisitions and regulatory due diligence is preferred.

If you believe that you have the passion and you are the right candidate, please share your resume at [email protected] within 7-10 days.

Pharmaris India

(Subsidiary of Pharmaris Canada Inc.)

Passion for Life

📌 Regulatory Affairs Manager (New Delhi)
🏢 Pharmaris India
📍 New Delhi