Head of Regulatory Policy, North America
The Head of Regulatory Policy, North America (aka Senior Regulatory Policy Advisor) is responsible for facilitating and defining strategic direction, leading Roche’s initiatives and activities, and favorably influencing the North America regulatory environment impacting the availability, manufacturing, marketing and distribution of Roche Diagnostics to improve Roche’s position resulting in significant impact internally within the business areas. This leadership role represents Roche, or facilitates appropriate Roche representation, 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, cooperating functional areas, Regions and Affiliates to create additional value based on strategic regulatory policy.
• Provides leadership and consultancy to the Diagnostics Division on regulatory policy and strategy related topics
• 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
• Works with the BAs/BUs/Global Functions/Regions/Affiliates to facilitate appropriately tailored changes mandated by a constantly changing regulatory environment, consistent with Divisional Standard.
• 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.
Who you are:
• 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 environment; Global experience a plus
• 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, etc.
• Excellent interpersonal, communication, and negotiation skills
Roche is an equal opportunity employer.
Regulatory Affairs, Regulatory Affairs > Regulatory Policy & External Influencing
Learn more here
Job posted: 2020-09-15