Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
l 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.
Pay: ₹40,000.00 - ₹45,000.00 per month
Perks:
- Flexible schedule
- Food provided
- Paid sick time
- Provident Fund