Genentech

Regulatory Affairs Specialist (Regulatory Policy Analyst)

Genentech  •  $85k - $158k/yr  •  Washington, DC (Onsite)  •  18 days ago
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Job Description

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.

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.

Benefits

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.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants

Genentech

About Genentech

About Genentech

We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal.

Making a difference in the lives of millions starts when you make a change in yours. If you’d like to join our team, view our openings at gene.com/careers.

Our patient resource center is dedicated to getting patients and caregivers to the right resources. You can reach them at 1 (877) GENENTECH (436-3683)

Monday-Friday, 6am-5pm PST or patientinfo@gene.com.

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Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
South San Francisco, California
Year Founded
1976
Website
gene.com
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