- The Senior Specialist/ Expert License Management prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet companys and health authorities requirements
- Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the license management strategy and approach
- Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs
- The role will have to work on complex tasks and to propose solutions and strategies as part of their day to day work
Who You Are:
- Experience: 8-12 years of work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role
- Education:Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
Job Specific Competencies & Skills:
- Ability to contribute to the dossier content and to perform content and quality review on regulatory documentation
- Ability to develop and prepare successful regulatory strategies and dossiers
- Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations
- Experience with life-cycle management activities in at least two regions (eg Europe, USA, International would be an asset)
- Solid experience in Regulatory Affairs regulatory dossiers and regulatory procedures on a global scale, including submission/registrations types and related requirements
- In Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (CP, MRP, DCP, National etc) and LCM strategies
- Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request
- Strong project management and documentation skills, proactive communication approach
- Ability to execute appropriate risk assessment and mitigation in cooperation with line manager /team lead
- Ability to provide Regulatory expertise into the planning and execution of projects and tasks
- Ability to work within a matrix organisation, build relationships with internal or external stakeholder
- Contributor level experience with RIM and EDMS RA applications
- Excellent written and spoken communication skills and English language knowledge
