Regulatory Affairs Executive

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