Regulatory Affairs Specialist (Regulatory Policy Analyst)

Genentech•Washington DC, DC

1d•Onsite

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