Manager - Medical & Regulatory Affairs

Roles & Responsibilities:

• Provide scientific inputs for new product development and evaluate product claims
• Review, validate, and approve product claims and medico-marketing materials
• Plan and conduct claim substantiation studies and scientific training for marketing teams
• Coordinate with third-party manufacturers for timely licenses and maintain license archival
• Respond to medical, regulatory, and consumer queries with accurate scientific information
• Monitor Adverse Events (AEs) and ensure pharmacovigilance and materiovigilance compliance
• Ensure quality, integrity, and regulatory compliance of all information shared with stakeholders
• Collaborate with internal teams including Marketing, QA, R&D, Supply Chain, and Business Development
• Liaise with external stakeholders such as KOLs, legal teams, consultants, and manufacturing partners
• Support business growth through regulatory strategy and compliance adherence

Qualification:

• M.Pharm or M.Sc in Pharmaceutical Sciences

Experience:
• 5-8 years of experience in Regulatory Affairs
• Prior experience in OTC drugs preferred
• Practical exposure to Pharmacovigilance and Materiovigilance processes

Skills:

• Strong knowledge of Indian regulations: D&C Act, DMR Act, UCPMP, ASCI Codes
• Ability to critically review scientific and regulatory documents
• Good analytical, communication, and presentation skills
• Strong coordination and stakeholder management abilities

About the Company:

Piramal Pharma Ltd., part of the diversified Piramal Group, is a leading global healthcare organization with a strong presence in consumer healthcare, pharmaceuticals, and life sciences. Guided by the values of Knowledge, Action, Care, and Impact, the company focuses on ethical practices, innovation, and inclusive growth. Through its Consumer Healthcare division, Piramal touches millions of lives across India with trusted OTC brands and a robust distribution network, while fostering a people-centric and high-growth work culture.