Regulatory Affairs Executive

NV Remedies Pvt Ltd

Pharmaceutical Trading & Healthcare Solutions

Executive — Regulatory Affairs

Full-time | On-site · 5 days/week | Navi Mumbai, Maharashtra, India | Mid-level

ABOUT THE ROLE

NV Remedies Pvt Ltd is a Mumbai-based pharmaceutical trading and healthcare solutions company specialising in generic formulations and Eastern European markets. We are looking for a driven Executive, Regulatory Affairs to join our growing team in Navi Mumbai. You will play a central role in managing regulatory submissions, dossier preparation, and ensuring compliance across domestic and international markets.

KEY RESPONSIBILITIES

• Prepare, compile, and submit regulatory dossiers (CTD/eCTD format) for generic medicines and biosimilars
• Liaise with regulatory authorities in regulated and semi-regulated markets, including Eastern Europe
• Support product registrations, renewals, and variations across target markets
• Assist in technology transfer documentation and production migration compliance
• Implement and maintain quality management systems in line with international standards
• Coordinate with third-party manufacturers and international partners on regulatory requirements
• Track regulatory updates and ensure timely action on changes affecting product portfolios

WHAT WE'RE LOOKING FOR

• B.Pharm / M.Pharm or equivalent; regulatory certification is a plus
• 2–4 years of experience in regulatory affairs within the pharmaceutical industry
• Hands-on experience with dossier preparation and regulatory submissions
• Familiarity with WHO, EU, or ICH guidelines for generic drugs and biosimilars
• Strong written communication and documentation skills
• Ability to manage multiple submissions and deadlines simultaneously

WHAT WE OFFER

• Exposure to international markets — Ukraine, Poland, and broader Eastern Europe
• Work directly with experienced regulatory and business development professionals
• Opportunity to contribute to proprietary and patented product development
• Collaborative, growth-oriented work environment

Interested candidates are invited to send their CV and cover letter to:

cfo@nv-remedies.com

Please mention “Application — Executive, Regulatory Affairs” in the subject line.