Synovia Pharma PLC.

Role Overview: Synovia Pharma PLC is seeking an experienced Senior Executive, Regulatory Affairs to oversee end-to-end product registration portfolios and ensure strict compliance with the Directorate General of Drug Administration (DGDA). Serving as a key liaison between the company and regulatory authorities, this role involves executing core operational tasks across manufacturing, commercial, and export operations while driving cross-functional alignment to meet strategic business objectives. Key Roles and Responsibilities: 1. Product Registration & Lifecycle Management Compile and submit detailed technical dossiers to the DGDA (Technical Sub-Committee and Drug Control Committee) for new brand registrations, line extensions, and product renewals. Oversee the approval pipeline for recipes, inclusion annexures, packaging materials, and Marketing Authorizations (MA). Review packaging text and artwork for strict compliance with DGDA design, layout, and content guidelines. Prepare and submit applications to secure approvals for product amendments, price setup (local and imported formulations), and No Objection Certificates (NOC). 2. Compliance, Licensing & Audits Organize and prepare documentation for the timely renewal of Manufacturing Licenses and Good Manufacturing Practices (GMP) certifications. Facilitate, coordinate, and support official DGDA site visits, audits, and inspection report finalizations. Track and drive the resolution of Corrective and Preventive Actions (CAPAs) related to regulatory audits and license renewals. 3. Supply Chain, Commercial & Vaccine Support Secure timely import approvals for Active Pharmaceutical Ingredients (APIs), excipients, packaging materials, and finished products (medicines and vaccines). Manage the submission and approval workflow for Lot Release Certificates (LRC) across the vaccine portfolio. Review marketing and promotional materials for medical accuracy and DGDA compliance prior to formal submission. 4. Export Operations & Regulatory Communication Handle export regulatory workflows, including international brand registrations and securing DGDA certificates/documents. Coordinate the legalization of export documentation with foreign embassies. Disseminate internal regulatory updates and provide guidance to departments for timely compliance. 5. Cross-Functional Collaboration & Projects Partner with Marketing, Medical Affairs, R&D/NPD, Export, Manufacturing, QC, Supply Chain, Finance, and HR teams to support routine operations and special initiatives. Execute additional strategic tasks and assignments provided by department superiors and executive management. 6. Global Principal Relations & Platform Management Maintain professional collaboration with global and regional Regulatory Affairs teams at Sanofi SA (France). Manage and update Sanofi's shared virtual platform (Veeva Vault) with current regulatory data, project statuses, and action logs. Ensure clear communication channels by providing regular updates to the Line Manager and Director on global principal activities and project milestones.