Regulatory Affairs Manager

Beschreibung

• Ensure that regulatory activities are effectively executed to meet the business objectives and legal requirements, in close collaboration with Regulatory Operations and other internal stakeholders
• Ensure regulatory compliance and maintenance of all product registrations and licenses throughout the whole life-cycle of the products under his/her responsibility
• Support in the provision of expert regulatory input to strategic decision making
• Write comprehensible, clear Regulatory Assessments and documents for internal and external stakeholders (e.g. Authorities and trade Associations)
• Ensure that regulatory submissions and other deliverable meet strict deadlines and fulfil European regulatory standards
• Keep up-to-date with changes in regulatory legislation and guidelines
• Support in the development and implementation of regulatory standards that convey the best practices in the regulatory department
• Establish strong relationships within the European Division, Regulatory Operations and Global Partners on a cross-functional basis including Marketing, Legal, Technical, Supply Chain, R&D, Regulatory and Product Safety
• Provide regulatory support on day-to-day regulatory issues, new initiatives and developments, including training to internal stakeholders and support to the Regulatory Affairs Managers in the hubs in topics related to the products and projects
• Provide assistance to authority inspections in the matters under Regulatory responsibility
• Ensure the review and approval of artworks and ingredient lists for products and regions
• Provide input for budget preparation and reviews
• Collaborate in regional and global regulatory projects and act as a project manager in the projects assigned to him/her (e.g. implementation of new IT systems, review and update of SOPs, etc)
• Contribute to an effective use of the network of regulatory consultants, including coordination with procurement and legal for contract negotiations and FCPA and Due Diligence processes

• Degree in a relevant scientific discipline (minimum BSc or equivalent, preferably with an MSc).
• Fluent in English and another European language.
• Good analytical skills and technical/ scientific competence
• Strong organizational skills
• Team player, proactive, quick learner and independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion
• Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance of medicinal products and the technical file (and ideally also medical devices, or other complex legislations)