Aprazer Healthcare Private Limited
Website:
aprazerhealthcare.com
Job details:
We are looking for an experienced and dynamic Regulatory Affairs Manager to join our pharmaceutical manufacturing facility in Haridwar. The ideal candidate should possess strong expertise in global regulatory requirements, dossier management, and coordination with international regulatory authorities.
This role is ideal for professionals who thrive in a fast-paced regulated environment and have hands-on exposure to international markets.
Key Responsibilities
• Preparation, review, compilation, and submission of regulatory dossiers for global markets.
• Handling CTD/eCTD submissions, variations, renewals, and responses to regulatory queries.
• Coordination with cross-functional departments including QA, QC, Production, R&D, and Business Development.
• Regulatory support for product registrations in semi-regulated and regulated markets.
• Review of artworks, packaging materials, and product-related regulatory documentation.
• Tracking updates in international regulatory guidelines and ensuring compliance.
• Supporting audits, inspections, and customer regulatory requirements.
Desired Candidate Profile
• B.Pharm (Bachelor of Pharmacy)
* M.Pharm (especially Pharmaceutics, Pharmacology, QA, Regulatory Affairs)
• Minimum 10 years of experience in Pharmaceutical Regulatory Affairs.
• Strong exposure to global markets including ROW, Africa, CIS, LATAM, ASEAN, EU, or other regulated/semi-regulated markets.
• Good understanding of CTD/eCTD formats and international regulatory requirements.
• Excellent communication, coordination, and documentation skills.
• Ability to independently manage multiple projects and timelines.
What We Offer
• Opportunity to work with an expanding global pharmaceutical organization.
• Exposure to international regulatory projects and markets.
• Professional growth in a compliance-driven environment.
• Competitive salary and performance-based growth opportunities.
📩 Interested candidates may share their CV at: info@aprazer.in
📞 Contact: 9654328222
Click on Apply to know more.