Regulatory Affairs Professional

1 week ago


Mumbai, Maharashtra, India Piramal Group Full time

Piramal Group seeks a highly skilled Regulatory Affairs Professional to support the development and commercialization of medical products. This individual will play a key role in ensuring compliance with regulatory requirements and providing scientific input for new product claims.

Responsibilities:
  • Prepare Red Books for key therapeutic targets
  • Provide scientific understanding and training to relevant stakeholders
  • Evaluate claims as per regulations and technical requirements
  • Conduct research studies to support claims
  • Handle consumer and medical queries received through consumer care

The successful candidate will have excellent communication and analytical skills, with the ability to critically review documents for scientific and regulatory compliance. A strong understanding of regulations such as the D&C Act, DMR Act, and UCPMP is essential.

Key Qualifications:

  • - years of experience in preparing Red Books and training teams
  • Previous regulatory experience in OTC drugs
  • Good understanding of operational process of PV Reporting
  • Critical review and validation skills

Working Arrangements:

  • This role will be based at our office location
  • We offer a competitive salary of $120,000 per annum


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