Regulatory Affairs Specialist (Regulatory Policy Analyst)

Posted Yesterday
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Washington, DC, USA
In-Office
85K-158K Annually
Junior
Healthtech • Biotech
The Role
Analyze FDA guidances and policy documents; conduct regulatory, policy, and legal research; perform landscape analyses to identify modernization opportunities; monitor policy proposals; coordinate internal communications, workgroups, and project activities; support policy positioning and advocacy; contribute to authoring white papers and guidance comments; engage internal and external stakeholders.
Summary Generated by Built In

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.

Skills Required

  • Bachelor's degree in life sciences
  • Advanced degree in life sciences
  • 1-2 years relevant experience in regulatory policy
  • Experience managing operations, research, and communications
  • Experience contributing to authoring white papers, guidance comments, or publications
  • Excellent interpersonal and communication skills
  • Ability to collaborate effectively with diverse stakeholders
  • High degree of judgment and insight
  • Relevant policy experience (internship or fellowship e.g., NIH, FDA)
  • Knowledge of device, diagnostics, and digital health
  • Knowledge of other regulatory systems and health authorities
  • Experience working with patient advocacy groups, non-profits, or academic societies

Genentech Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.

  • Healthcare Strength Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
  • Retirement Support Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
  • Leave & Time Off Breadth Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.

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The Company
HQ: South San Francisco, CA
20,069 Employees
Year Founded: 1976

What We Do

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. 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.

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