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1G
1000 Genentech, Inc.
Regulatory Affairs Specialist (Regulatory Policy Analyst)
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Based on Washington, D.C. (District of Columbia) data
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What they do
A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
$114,682 / year median in Washington, D.C. (District of Columbia)
-1% projected decline
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