Regulatory Affairs

institute logo

Regulatory Affairs

work outline icon0 - 5 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Lyrus Life Science Pvt. Ltd.

time outline iconBengaluru Rural, Karnataka, India

Posted on 16-12-2025

1 Vacancy

Description

  1. Prepare and submit regulatory dossiers for product approvals to national and international authorities.
  2. Ensure compliance with local and global regulatory requirements (FDA, EMA, CDSCO, etc.).
  3. Monitor changes in regulations and provide guidance to internal teams.
  4. Liaise with regulatory authorities during product registration, inspections, and queries.
  5. Review product labeling, promotional materials, and documentation for regulatory compliance.
  6. Coordinate with R&D, QA, production, and marketing teams for regulatory submissions.
  7. Maintain up-to-date knowledge of regulatory guidelines, industry standards, and compliance requirements.
  8. Support audits, inspections, and submission of responses to regulatory observations.
  9. Prepare technical reports, summaries, and dossiers for new products, variations, and renewals.


Category

Pharmaceuticals

Key Skills

CommunicationProblem SolvingMultitaskingTeam WorkAttention to Detail

Aggregated job.

Learn more