Company: Invex Health Pvt Ltd
Post: Regulatory Affairs
Experience: 1-4 yrs
Qualification: B. Pharmacy
Location: Mumbai
Roles and Responsibilities
- Responsible for registration of Pharmaceutical & Nutraceutical.
- Identifying consultants wherever registration needs to be initiated.
- Coordinating & follow-up up with the suppliers regulatory team for document review, compilation & submission to the necessary authority.
- Determine regulatory pathway for import of products along with details like cost, timeline, documentation, etc.
- Apply for necessary licenses/ certificates on Regulatory portals like CDSCO, FSSAI, etc.
- Preparation, collation & review of the registration documents pertaining to product registrations.
- Coordinating with the clients regulatory team for providing the necessary documents.
- Responsible for resolving queries on time raised by the registering authority/ consultant/ distributor.
- Communicating with consultants/ distributors for product registrations/tenders etc.
- Follow up and coordinate with various departments across the company to collate documents required for regulatory submissions on time.
- Maintain product registration records to ensure proper documentation.
- Preparing and maintaining a regulatory budget sheet.
- Draft policies and SOPs for the company from a quality perspective.
- Prepare labelling & artwork requirements as per specific country requirements for export or domestic purpose.
Desired Candidate Profile
- Graduate with minimum 1-3 years of experience in Pharmaceutical dossier preparation is mandatory
- Bachelors in B. Pharm (preferred) or any other science graduate.
- Immediate joining is preferred.
- Excellent Written & Verbal English communication.
- Self-starter & energetic.
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