Senior Executive/Assistant Manager - Regulatory Affairs

Role & responsibilities

Market Experience : Australia / New Zealand / South Africa / EU / UK/ WHO

• Preparation, compilation, review, and submission of new product registrations, and duplicate marketing authorizations for assigned projects. Due diligence for product registration documents and compilation of requirement matrix.
• Compilation, review, and submission of documents and timely co-ordination with Agencies until approval from national authority.
• Preparation and compilation, review, and submission of responses of deficiencies received from Agency and MAH.
• Review and finalization of operational and technical documents and assessment protocols and reports. Handling of Document management system for review and archival of specification.
• Preparation and Review of SmPC, Patient information and Labelling. Review and finalization of artworks.
• Coordination and follow up, communication of regulatory update with cross functional team. Liaising with MAHs and Clients for different documents, variation and new product registration.
• Maintenance and timely updation of Regulatory Database for approved products and providing information to CFT/MAH/Clients/BD about regulatory submission and approvals via Product Master Form.
• Evaluation of impact assessment of Change controls, Change Notifications, pharmacopoeia notification, CFT proposal etc. Technical and Regulatory support for Product launch and exhibit batches execution.
• Liaising / attending meeting with external stake holder/ affiliate for different documents, variation and new product registration and to keep track of the out-licensed/ in-licensed projects
• Literature search, gap assessment and feasibility evaluation for new product, extention applications and variations.
• Scientific advice and Co-ordination with the Agencies for the guidance related to new product development and variation activities.
• Coordination and communication, Tracking, RA review and Support for EU and UK Agency and Office bearer invoices for timely payment
• Preparation, maintenance and archival of tracking spreadsheets for monthly and annual developments (Monthly dashboards/Project tracker/ Nitrosamine status)

Preferred candidate profile