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Regulatory Affairs Manager

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Recruiter: Real Staffing
Listed on: 22nd November
Location: Basel
Type: Contract

Regulatory Affairs Manager -Medicinal Products & Food Supplements

Location: 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 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

Requirements:

  • 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)

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.

Contact Name: Julia Pensin
Reference: TJ/3386/RE-33794987_1637596049
Job ID: 3008878



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