Regulatory Affairs Executive
4 days ago
Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategiesl Knowledge of ICH guidelines, CTD dossiers.
l Assist in preparing and compiling necessary documents for regulatory submissions.
l Coordination with manufacturer for collecting documents for preparation of dossier, review of dossier and submission to respective regulatory authority
l Coordinate with the manufacturer to gather necessary information for submission processes.
l Follow-up with manufacturing site for register sample, working standard & impurity requirement for lab analysis.
l To prepare monthly regulatory status report and status of new registration/Re-registration/post approval changes.
l Review of artwork and pack insert as per rules laid by respective regulatory authority.
l Maintain accurate and up-to-date regulatory documentation
l Stay updated on changes in regulatory requirements and communicate these changes to relevant stakeholders within the company.
l provide regulatory input for product development, including reviewing and approving labeling, packaging, and promotional materials.
l Collaborate with international partners, conduct factory inspections, and ensure compliance with regulatory requirements.Ability to travel to factories, events, and other locations as needed for inspections and other business purposes.
l B. Pharma or M. Pharma with at least 2 of Experience working in reputed Pharma Company.
l Fluent in oral and written English to effectively communicate with regulatory bodies and international partners.
**Job Types**: Full-time, Permanent
Pay: ₹20,000.00 - ₹30,000.00 per year
**Education**:
- Doctorate (preferred)
**Experience**:
- total work: 2 years (preferred)
**Language**:
- English (preferred)
Work Location: In person
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