Phamaceutical Regulatory Affairs Manager France - France
- Our company is the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services.
- Our company services are targeting support for comprehensive compliance and safety throughout the product life cycle, therefore enabling continuity and productivity of product development and subsequent processes.
- As a result of the deployment of a new project we are now seeking a Regulatory Affairs Manager responsible for ensuring delivery of regulatory services by the RA Southern EU platform.
Under the monitoring of the RA Platform Leader your missions are:
- Manage or supervise the compilation of regulatory files respecting national requirements (France/ EU).
- Obtain regulatory approvals.
- Provide regulatory advice to project teams to ensure the inclusion of regulatory concerns in relevant data planning and production to achieve the project objectives.
- Provide regulatory support to clients and associates.
- Liaising with regulatory authorities as required.
- To review the format and content of the texts related to packaging, summaries of product characteristics, labeling and records.
- Review the tasks, provide support and assist in charge of Regulatory Affairs and Regulatory affairs
- Assist Platform managers / or regulatory Hub consultants Senior Regulatory Affairs before sales
- Provide technical support before sales
- Ensure adequate technical description of the proposals and provide support for sales in costing
- Ensures that invoicing is correctly set. Validate invoices.
- Controls data entry of the Platform/Hub staff in PLG tools. Ensures KPI, metrics for all regulatory services supplied by the platform/the hub are adequately measured and reach or exceed defined targets
- Education Master or higher graduate degree in a science related field
- Experience: 5 years minimum of professional experience required in a similar position in regulatory affairs and project management
- Expert in French /EU regulatory affairs registration and related fields
- Excellent organizational and interpersonal skills
- Ability to coordinate, lead and motivate a team
- You are fluent in English and/ or Portuguese and/ or Spanish (spoken and written) for daily contacts with local and internationally partners.
- Project management skills
- Rigorous and Pragmatic
- Customer- and Quality focus
- Result driven , accurate
- Problem solving capabilities
- Competitive salary package
- Training and development
- International and growing company
- Dynamic environment