Regulatory Affairs Specialist (Regulatory Policy Analyst)
About The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Genentech, a member of the Roche Group! 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
- Discretionary annual bonus may be available based on individual and Company performance
- Benefits detailed at the link provided below
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
