Regulatory Affairs Manager
4 weeks ago
Job Title:
We are seeking a skilled Regulatory Affairs Manager to join our team at Piramal Group. 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 teams, responding to medical & regulatory queries, providing scientific support for consumer queries, reviewing and approving medico-marketing material, monitoring Adverse Events, ensuring quality & integrity of information being shared with stakeholders, collaborating with others in the organization to contribute to the success of the business.
Key Responsibilities:
- 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
Requirements:
- Previous experience in preparing Red Books and training teams
- Previous regulatory experience in OTC drugs
- 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
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