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Head Environmental Regulatory Affairs(m/w/x)
External representation for diagnostics, tracking global regulatory changes and mQMS GSP01 alignment. 10+ years product-related regulatory experience required. Influence on global regulatory strategy for personalized medicine diagnostics.
Requirements
- Master of Science degree in chemistry, biology, or related field
- 10+ years of experience working on product-related environmental regulations
- Expert communication skills with ability to influence stakeholders
- Strong experience working within industry associations and with authorities
- Strategic visionary with strong relationship-building skills
- Commitment to radical simplification and innovative leadership
Tasks
- Lead and coordinate representation in external associations
- Represent Diagnostics in cross-functional committees
- Track and monitor global environmental regulatory changes
- Support implementation strategy for regulatory requirements
- Align and implement mQMS GSP01 requirements
- Provide expert support and guidance to sites and affiliates
- Lead the team with strategic direction and guidance
- Create opportunities for employee development and training
- Establish and lead Diagnostics affiliate networks
- Partner with the Dia Regulatory Policy Team for expert advice
- Manage budget responsibilities
- Participate in the Diagnostics Product Sustainability and Compliance leadership team
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Not a perfect match?
- Roche Diagnostics Int. AGFull-timeOn-siteSeniorRisch-Rotkreuz
- Roche Diagnostics Int. AG
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Head Environmental Regulatory Affairs(m/w/x)
External representation for diagnostics, tracking global regulatory changes and mQMS GSP01 alignment. 10+ years product-related regulatory experience required. Influence on global regulatory strategy for personalized medicine diagnostics.
Requirements
- Master of Science degree in chemistry, biology, or related field
- 10+ years of experience working on product-related environmental regulations
- Expert communication skills with ability to influence stakeholders
- Strong experience working within industry associations and with authorities
- Strategic visionary with strong relationship-building skills
- Commitment to radical simplification and innovative leadership
Tasks
- Lead and coordinate representation in external associations
- Represent Diagnostics in cross-functional committees
- Track and monitor global environmental regulatory changes
- Support implementation strategy for regulatory requirements
- Align and implement mQMS GSP01 requirements
- Provide expert support and guidance to sites and affiliates
- Lead the team with strategic direction and guidance
- Create opportunities for employee development and training
- Establish and lead Diagnostics affiliate networks
- Partner with the Dia Regulatory Policy Team for expert advice
- Manage budget responsibilities
- Participate in the Diagnostics Product Sustainability and Compliance leadership team
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Business Fluent
About the Company
Roche Diagnostics Int. AG
Industry
Healthcare
Description
The company is dedicated to advancing personalized medicine and improving patient lives through innovative diagnostics and healthcare solutions.
Not a perfect match?
- Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Sanofi International AG
Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Full-timeOn-siteSeniorZug - Roche Diagnostics Int. AG
Alliance & Ecosystem Management (AEM) Sub-Chapter Lead(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz