
Deputy Manager-Regulatory Affairs
Axxelent Pharma Science Private Limited, Chennai
Nadu, Tamil Nadu, India
Posted on 03-09-2025
1 Vacancy
Description
- Lead and manage regulatory submissions for domestic and international markets (CTD/eCTD).
- Oversee product registrations, renewals, variations, and regulatory approvals.
- Ensure compliance with global regulatory guidelines (USFDA, EMA, MHRA, WHO, CDSCO, etc.).
- Act as a liaison with health authorities and handle regulatory inspections and audits.
- Review and approve technical documents, labeling, artwork, and promotional materials.
- Develop and implement regulatory strategies for new product development and lifecycle management.
- Coordinate with R&D, QA, QC, and Production teams for timely documentation.
- Guide, mentor, and train junior staff in regulatory processes and best practices.
- Maintain and update regulatory records, SOPs, and databases as per standards.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Preferred Education
MPharm (Master Of Pharmacy)BPharm (Bachelor Of Pharmacy)
Key Skills
Attention to DetailCommunicationTeam WorkProblem Solving
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