Beschreibung
REGULATORY AFFAIRS MANAGERLocation: Basel
Tasks:
- 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 deliverables 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
Requirements:
- Degree in a relevant scientific discipline (minimum BSc or equivalent, preferably with an MSc).
- Fluent in English and another European language.
- Experience with Consumer Care products.
- Skilled in writing module 3/CMC.
- Mutual Recognition Procedure (MRP) / Decentralised Procedure (DCP)
- 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).
Keywords:
Pharmaceuticals, CMC, MRP, DCP, Regulatory, Regulations, Dossier, Medicinal Products, Legislations, Regulatory Assessments, Regulatory Submissions, Regulatory Affairs, Regulatory Affairs manager, Schweiz, Switzerland, Basel
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.