Position:
Senior Regulatory Group Director
Company:
Roche
Location:
Switzerland, Basel
Employment type:
Full time
Short Summary:
In this leadership position in Pharma Technical Regulatory (PTR), you will oversee regulatory strategies and initiatives, advocate for changes, and support teams in an agile environment to ensure access to healthcare.
Responsibilities:
- Oversee the development and implementation of end-to-end regulatory strategies on a portfolio level.
- Define long-term vision and strategies across product portfolios and initiatives.
- Enable self-managed teams and take responsibility for performance management and development discussions.
- Collaborate globally with leaders to align on priorities and support strategic projects.
- Lead health authority interactions and submission reviews for assigned projects.
- Build and maintain relationships with key internal stakeholders and communicate challenges and opportunities.
- Anticipate and remove organizational barriers to progress.
Requirement:
- Master’s or Post Graduate Degree in life sciences.
- 15+ years of experience in the pharmaceutical or biotechnology industry with global CMC regulatory leadership experience.
- Deep expertise in global CMC regulatory landscapes and hands-on experience in scenario planning and regulatory risk assessment.
- Strong technical understanding of drug manufacturing and analytics, drug development, and Pharmaceutical Quality Systems.
- Proven track record in people management and global team leadership with excellent communication skills.
- Strategic perspective on Regulatory Information Management systems and digital tools.
- Willingness to travel up to 10%.
Benefits:
- Opportunity to lead and innovate in a meaningful role.
- Join a global team dedicated to advancing science and healthcare access.
- Work in a culture that encourages personal expression and professional growth.