Manager - Medical & Regulatory Affairs

2 weeks ago

Mumbai, Maharashtra, India Piramal Group Full time

JOB OVERVIEW: The incumbent will be responsible for providing scientific inputs for new product development, reviewing and approving product claims, conducting claim substantiating studies, conducting scientific training for marketing team, responding to medical & regulatory queries, provide scientific support for consumer queries, reviewing and approving medico-marketing material, monitoring AEs, ensuring quality & integrity of information being shared with stakeholders, collaborating with others in the organization to contribute to success of the business

KEY STAKEHOLDERS: INTERNAL Marketing, Supply Chain, Quality Assurance, R&D, Sales, Business Development

KEY STAKEHOLDERS: EXTERNAL KOLs, Corporate Legal

REPORTING STRUCTURE: Chief Manager – Medical and Regulatory Affairs

EXPERIENCE:
• - years of experience
• Previous experience in preparing Red Books and training teams
• Previous regulatory experience in OTC drugs
• Has a good understanding of the operational process of PV Reporting
• Ability to critically review documents for scientific and regulatory compliance and validate scientific claims for products
• Well-versed with regulations such as D&C Act, DMR Act, UCPMP

Key Roles/Responsibilities: Scientific Support
• Prepare Red Books for key therapeutic targets
• Provide scientific understanding and training to relevant stakeholders
• Support marketing in evaluating NPDs, finalizing product claims and reviewing new artworks and promotional material
• Evaluate claims as per regulations and technical requirements
• Conduct research studies to support claims
• Provide medical and regulatory support for assigned projects Consumer Care
• Handle consumer and medical queries received through consumer care
• Review FAQs to consumer care team
• Provide scientific training to consumer care Regulations & Compliance
• Read and understand all regulatory requirements as per business needs
• Conduct complete and thorough review of artworks, labels, pack inserts, promotional material – banners, leaflets, print ads, TVC, social media campaigns
• Execute tasks as per SOPs and work processes
• Liaise with internal stakeholders to ensure OTIF delivery of projects
• Ensure all regulatory obligations are met Other Skills
• Interact and maintain relations with cross-functional team
• Ability to independently manage assigned tasks
• Basic IT knowledge

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