
Regulatory Affairs
Lyrus Life Science Pvt. Ltd.
Bengaluru Rural, Karnataka, India
Posted on 16-12-2025
1 Vacancy
Description
- Prepare and submit regulatory dossiers for product approvals to national and international authorities.
- Ensure compliance with local and global regulatory requirements (FDA, EMA, CDSCO, etc.).
- Monitor changes in regulations and provide guidance to internal teams.
- Liaise with regulatory authorities during product registration, inspections, and queries.
- Review product labeling, promotional materials, and documentation for regulatory compliance.
- Coordinate with R&D, QA, production, and marketing teams for regulatory submissions.
- Maintain up-to-date knowledge of regulatory guidelines, industry standards, and compliance requirements.
- Support audits, inspections, and submission of responses to regulatory observations.
- Prepare technical reports, summaries, and dossiers for new products, variations, and renewals.
Category
Pharmaceuticals
Key Skills
CommunicationProblem SolvingMultitaskingTeam WorkAttention to Detail
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