Senior Executive, Regulatory Affairs

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.