? WE’RE HIRING | PHARMA REGULATORY AFFAIRS MANAGER

? Location: Pune, Maharashtra

? Experience: 7–8 Years

? Industry: Pharmaceutical

? Qualification: B.Pharm / M.Pharm / Relevant Scientific Discipline

About the RoleWe are looking for an experienced and detail-oriented Pharma Regulatory Affairs Manager to join our team in Pune.

The ideal candidate will have strong expertise in global regulatory affairs, regulatory submissions, product registrations, and compliance requirements across international markets. The role will involve developing regulatory strategies, managing submissions, coordinating with cross-functional teams, and liaising with regulatory authorities to support successful product approvals and commercialization.

Key Responsibilities? Develop and implement regulatory strategies for pharmaceutical products across global and regional markets.

? Prepare, review, and coordinate regulatory submissions in accordance with US, EU, ICH, and regional regulatory requirements.

? Liaise with regulatory authorities and respond to queries to facilitate timely approvals.

? Monitor changes in regulatory guidelines and assess their impact on product development and commercialization.

? Collaborate with R&D;, Quality, Clinical, Legal, and other cross-functional teams to provide regulatory guidance throughout the product lifecycle.

? Support regulatory documentation for clinical trials, including protocols, Investigator Brochures, and informed consent documents.

? Conduct regulatory risk assessments and provide recommendations to ensure compliance and product safety requirements.

? Participate in regulatory audits and inspections and support implementation of corrective and preventive actions.





? Provide regulatory training and guidance to internal stakeholders.

Candidate Profile✅ 7–8 years of experience in Pharmaceutical Regulatory Affairs, preferably with exposure to international markets.

✅ Bachelor’s degree in Pharmacy or a related scientific discipline; M.Pharm / Master’s degree preferred.

✅ Strong knowledge of FDA regulations, 21 CFR Part 11, ICH guidelines, EU regulations, and other regional requirements.

✅ Proven experience in managing regulatory submissions and supporting successful product approvals.

✅ Solid understanding of pharmaceutical product registration and regulatory compliance processes.

✅ Excellent project management and organizational skills with the ability to manage multiple priorities.

✅ Strong written and verbal communication skills.

✅ Analytical, problem-solving, and decision-making abilities.

✅ Experience with Regulatory Information Management (RIM) systems and regulatory software tools will be an advantage.

Why Join Us?? Work on global regulatory affairs and international pharmaceutical markets

? Collaborate with cross-functional teams and industry professionals

? Chance to contribute to product registrations, approvals, and commercialization

? Be part of a growing pharmaceutical organization with international business exposure

? Apply NowIf you have strong experience in Pharmaceutical Regulatory Affairs and are looking for an opportunity to take your career to the next level, we would love to hear from you.

? Send your CV to: [email protected]

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📌 PHARMA REGULATORY AFFAIRS MANAGER (Pune)
🏢 SPPL India
📍 Pune