Full Job Description
As the Regulatory Policy Analyst , you will be a member of our Regulatory group working with both internal and external stakeholders to proactively shape regulatory environments to enhance patient access to the Roche/Genentech portfolio. In this role, you serve as key contact on regulatory policy and advocacy.
The Opportunity
• You will analyze FDA guidances and other policy documents to inform the business
• You will conduct regulatory, policy and legal research on topics identified by senior leaders
• You will conduct external and internal landscape analysis to identify near and long-term opportunities to modernize FDA and the regulatory ecosystem
• You will promote internal awareness of key regulatory policy activities by coordinating communications and implementation considerations across functions
• You will monitor relevant outlets for policy proposals that impact business and ensure internal awareness of the same
• You plan and manage projects under the direction of policy lead(s) and management.
• You coordinate internal work groups to support alignment on policy positions and strategies.
Who You Are
• You have a Bachelor’s degree in life sciences, advanced degree preferred
• 1-2 years relevant experience in regulatory policy
• Demonstrated track record in managing operations, research and communications
• Contributing to authoring white papers, guidance comments, publications
• Excellent interpersonal and communication skills.
• High degree of judgment and insight.
• Collaborate effectively with a diverse group of stakeholders
Preferred Qualifications:
• Advanced degree in life sciences
• Relevant policy experience, including experience gained through internship or fellowship (Ex. NIH, FDA, Non-profit or similar)
• Knowledge of device, diagnostics and digital health a plus
• Knowledge of other regulatory systems and health authorities a plus
• Knowledge and experience working with patient advocacy groups, non-profits and relevant academic societies
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of Washington, D.C. is $85,000 - $157,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.