United States, Indiana, Indianapolis
District of Columbia
The Regulatory Policy Advisor is responsible for facilitating and defining strategic direction, leading Roche’s initiatives and activities, and favorably influencing the regulatory environment impacting the availability, manufacturing, marketing and distribution of Roche Diagnostics products in the US and/or external forums within the diagnostic community to improve Roche’s position resulting in significant impact internally within the business area. This leadership role represents Roche on all types of policy and standards setting forums to ensure Roche’s interests are considered; is a key subject matter expert and technical liaison externally to industry organizations or customers and opinion leaders and/or advocacy and patient interest groups, and internally to various departments and cooperating functional areas to create additional value based on strategic regulatory policy.
• Provides leadership and consultancy to the Diagnostics Division on regulatory policy and strategy related topics. Works with the BAs/BUs/Global Functions/Affiliates to facilitate appropriately tailored changes mandated by a constantly changing regulatory environment.
• Identifies and leads regulatory policy and strategy initiatives that will lead to a more favorable regulatory environment in which to operate.
• Develops and implements regulatory strategies and tactics to enhance Roche’s ability to be nimble in a changing regulatory environment.
• Supports BAs/BUs to maintain an appropriate level of regulatory environment awareness throughout the organization.
• Supports regulatory intelligence efforts and communications
• Subject matter expert for key regulatory policy and strategy areas.
• Supports team efforts related to people development and engagement.
• May establish and manage program’s budget and resources.Read more
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
• B.S. in scientific field with 10+ years of diagnostics or related experience or M.S. with 7+ years of diagnostics or related experience or Ph.D. or JD with 5+ years of diagnostic or related experience
• Subject matter expert in regulatory processes, laws and regulations, with a strong understanding of both the informal and formal aspects of how regulatory policy is shaped and developed
• Thorough knowledge of US regulatory including FDA, FDA staff and FDA policies. Must have complete understanding of the Federal Food Drug and Cosmetic Act and associated regulations and guidances
• Demonstrated ability to execute innovative approaches to complex projects.
• Demonstrated ability to collaborate effectively and influence diagnostic, device or drug community both internally and externally
• Strategic Planning / Technical Leadership / Project Leadership skills
• Exceptional writing skills, including ability to write evidence-based advocacy documents
• Experience working with and negotiating successful outcomes with external agencies including CLSI, AACC, IFCC, FDA, RiliBAK, SAMHSA, etc.
• Strong interpersonal, communication, and negotiation skills
• Position may require significant travel if candidate does not reside in Washington, D.C.
At Roche, 91,700 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Location United States, Indiana, Indianapolis | District of Columbia
Function Regulatory Affairs
Job level Executive (Director/VP/SVP)
Job type Regular Employee