Regulatory Affairs Specialist (Regulatory Policy Analyst)

Roche • Washington, DC

3d • $85,000 - $157,800

About The Position

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.

Requirements

• Bachelor’s degree in life sciences
• 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

Nice To Haves

• 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

Responsibilities

• Analyze FDA guidances and other policy documents to inform the business
• Conduct regulatory, policy and legal research on topics identified by senior leaders
• Conduct external and internal landscape analysis to identify near and long-term opportunities to modernize FDA and the regulatory ecosystem
• Promote internal awareness of key regulatory policy activities by coordinating communications and implementation considerations across functions
• Monitor relevant outlets for policy proposals that impact business and ensure internal awareness of the same
• Plan and manage projects under the direction of policy lead(s) and management
• Coordinate internal work groups to support alignment on policy positions and strategies

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level