
Executive/Sr. Executive-Regulatory Affairs
Axxelent Pharma Science Private Limited, Chennai
Chennai, Tamil Nadu, India
Posted on 03-09-2025
1 Vacancy
Description
- Prepare, review, and submit regulatory documents (CTD/eCTD, dossiers) to health authorities.
- Ensure compliance with national and international regulatory requirements.
- Coordinate with R&D, QA, QC, and Production teams for data collection and document preparation.
- Maintain updated knowledge of global regulatory guidelines (USFDA, EMA, MHRA, CDSCO, etc.).
- Handle product registration, renewals, variations, and licensing activities.
- Respond to queries from regulatory agencies within defined timelines.
- Review labeling, packaging, and promotional materials for regulatory compliance.
- Support audits and inspections by regulatory authorities.
Category
Pharmaceuticals
Preferred Education
MPharm (Master Of Pharmacy)BPharm (Bachelor Of Pharmacy)
Key Skills
Attention to DetailCommunicationTeam WorkProblem Solving
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