Executive - Regulatory Affairs & Pharmacovigilance

<h2><b>Job Description:</b></h2><p>The key activities include:</p><ul><li>Reporting of safety information from India &amp; India cluster (South Asia countries) to the Global Safety</li><li>Follow up for additional information with the reporters</li><li>Review safety mailbox for the reports</li><li>Monthly Reconciliation and Compliance checks from PV perspective</li><li>Submission of Periodic Safety Update Reports to the regulatory authority as per regulations</li><li>Gathering the requirements and Preparation of dossiers for submission to the Indian regulatory authority for new products, clinical trials, variations,  renewals of registration certificates, etc. , preparation for query responses to the authority, coordination with the global teams</li><li>Contribute in preparation for regulatory authority meetings and expert committee meetings</li><li>Preparation of dossiers for regulatory submissions and followups for South Asia countries</li><li>Preparation and updation of labeling materials for our products</li><li>Promotional material review in compliance with product registrations</li><li>Timely information for updation of Regulatory Databases</li><li>Updation of local SOPs</li><li>Updation / renewal of  Safety Agreements for Partners, Manufacturers, Distributors</li><li>Coordination and checks for price updates and entry of information timely into the Pricing Authority database (NPPA)</li><li>Lifecycle maintenance, and update commercial team in a timely manner of major milestones</li></ul><p></p><p>Qualification: Bachelors in Pharmacy or Lifesciences or Microbiology, Chemistry, or similar</p><p>Experience: 1 &#43; years in India Regulatory Affairs and Pharmacovigilance functions in Pharma or Biotech Industry</p><h2><b>Location:</b></h2>Ferring India M&amp;S