Zieva Farm Pvt Ltd

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