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
