Manager – Medical & Regulatory Affairs
Company: Piramal Consumer Healthcare
Location: Kurla, Mumbai, Maharashtra, India
Department: Regulatory Affairs
Employment Type: Full-Time
Travel Requirement: Low
Experience Required: 5–8 Years
Job Overview
Piramal Consumer Healthcare is seeking an experienced Manager – Medical & Regulatory Affairs to provide scientific, medical, and regulatory leadership across consumer healthcare and OTC portfolios. The role will support new product development, regulatory compliance, claim substantiation, pharmacovigilance oversight, and medico-marketing governance, while collaborating closely with cross-functional teams and external stakeholders.
This position is critical in ensuring scientific accuracy, regulatory adherence, and quality of medical information shared across internal and external platforms.
Key Responsibilities
Provide scientific and medical inputs for new product development, lifecycle management, and innovation initiatives.
Review, validate, and approve product claims in compliance with applicable regulatory and scientific standards.
Design, oversee, and evaluate claim substantiation and scientific studies for consumer healthcare and OTC products.
Review and approve medico-marketing and promotional materials to ensure compliance with regulatory and ethical guidelines.
Conduct scientific and medical training programs for marketing and commercial teams.
Coordinate with third-party manufacturers to obtain regulatory licenses in a timely manner and ensure proper license archival.
Respond to medical, scientific, and regulatory queries from internal teams, consumers, and external stakeholders.
Provide scientific support for consumer inquiries and ensure accuracy and integrity of shared information.
Monitor, document, and manage Adverse Events (AEs) in alignment with Pharmacovigilance and Materiovigilance requirements.
Ensure compliance with applicable Indian regulations, including Drugs & Cosmetics Act, Drugs and Magic Remedies Act, UCPMP, and ASCI codes.
Collaborate with cross-functional stakeholders including Marketing, Quality Assurance, R&D, Supply Chain, Business Development, and Consumer Insights to support business objectives.
Maintain high standards of documentation, governance, and regulatory compliance across all medical and regulatory activities.
Key Stakeholders
Internal:
Marketing, Supply Chain, Quality Assurance, Research & Development, Business Development, Analytical, Packaging, Consumer Insights
External:
Key Opinion Leaders (KOLs), Corporate Legal Teams, Third-Party Manufacturing Partners, Regulatory Consultants
Reporting Structure
Reports to Chief Manager – Regulatory Affairs
Required Qualifications & Experience
Education: M.Pharm or MSc in Pharmaceutical Sciences from a recognized institution.
Experience:
Minimum 5–8 years of relevant experience in Medical Affairs and Regulatory Affairs roles.
Prior regulatory experience in OTC drugs or consumer healthcare products is strongly preferred.
Solid understanding of Pharmacovigilance and Materiovigilance operational processes.
Proven ability to critically review scientific, regulatory, and medico-marketing documents.
Strong knowledge of Indian regulatory frameworks including D&C Act, DMR Act, UCPMP, and ASCI guidelines.
Excellent analytical, documentation, communication, and presentation skills.
Ability to work independently and collaboratively in a cross-functional, matrix-driven environment.
About Piramal Consumer Healthcare
Piramal Consumer Healthcare is a leading consumer health division of Piramal Pharma Limited, committed to delivering high-quality, science-backed healthcare solutions across multiple categories including skin care, digestive health, women’s health, pediatrics, pain management, oral care, respiratory health, nutraceuticals, and food supplements. Backed by the legacy of the Piramal Group, the organization continues to grow rapidly with a strong focus on ethics, innovation, and consumer-centricity.
Equal Employment Opportunity
Piramal Group is an Equal Employment Opportunity and Affirmative Action employer. Employment decisions are based on merit, qualifications, and performance, without discrimination on any legally protected basis. The organization is committed to providing an inclusive and supportive workplace with reasonable accommodations where required.
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