Key skills
Communication
About this role
Role Overview
- Lead development and execution of regional regulatory strategies for precision medicine and digital health assets
- Coordinate regulatory interactions with local and regional health authorities and external partners
- Provide regulatory input to cross-functional project teams from early development through lifecycle management
- Ensure regulatory compliance for companion diagnostics, software as a medical device (SaMD), and digital health components
- Interpret regulatory feedback and translate it into clear operational plans and submission materials
- Mentor and coach colleagues to build regulatory capability across the business.
Requirements
- Bachelor’s degree in biological science, healthcare science, engineering or equivalent
- Experience working in the pharmaceutical industry, MedTech industry or regulating authorities
- Practical experience with regulation of companion diagnostics and/or SaMD
- Proven track record leading development, submission and approval activities in one or more regions
- Experience preparing for and leading regulatory milestone meetings and authority interactions
- Strong written and verbal communication skills and ability to work in a matrix environment.
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
- annual bonus
- eligibility to participate in our share based long term incentive program