Senior Manager of Regulatory Affairs supporting regulatory activities for oncology clinical studies. Collaborating with cross - functional teams to ensure compliance and successful submissions to regulatory agencies.
About the role
- Global Regulatory Strategy Director leading CNS drug development projects. Managing regulatory strategies and stakeholder interactions within a collaborative team environment in Denmark.
Responsibilities
- Take regulatory strategic leadership responsibility for development projects
- Work on innovative regulatory strategies and define regulatory tactics
- Provide input to clinical development plans and evaluate regulatory risks
- Lead Health Authorities interactions and chair regulatory focus team
- Contribute to internal improvement projects and department activities
Requirements
- PhD degree in life science or medical discipline is an advantage
- Profound experience with global regulatory strategies
- High degree of scientific and value chain understanding
- Experience in drug development of CNS, biologics, and/or rare diseases is a clear advantage
- Innovative mindset and solid matrix leadership skills
- Advanced communication skills in written and spoken English
Benefits
- Health insurance
- Professional development opportunities
- Flexible working options
- Contribution to well-being and diversity initiatives
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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