Roche

Regulatory Affairs Specialist (Regulatory Policy Analyst)

Roche$85K — $157K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor’s degree in life sciences; advanced degree preferred
  • 1-2 years experience in regulatory policy
  • Proven ability in managing operations, research, and communications
  • Experience in writing white papers and guidance comments
  • Strong interpersonal and communication skills
  • High degree of judgment and insight
  • Ability to collaborate with diverse stakeholders

Responsibilities

  • Analyze FDA guidances and other policy documents
  • Conduct regulatory, policy, and legal research as directed by senior leaders
  • Perform landscape analysis to identify opportunities in FDA modernization
  • Coordinate communication and implementation of key regulatory activities internally
  • Monitor policy proposals impacting the business and ensure internal awareness
  • Plan and manage policy-related projects under guidance of management
  • Coordinate work groups to align policy positions and strategies

Benefits

  • Discretionary annual bonus based on performance
  • Health, dental, and vision insurance
  • 401(k) retirement plan with company match
  • Paid time off including vacations and holidays
  • Opportunities for professional development and training
Full Job Description
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.

About Roche

Roche Holding AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel. Roche is the largest pharmaceutical company in the world, and the leading provider of cancer treatments globally. The company also produces a range of diagnostic tests for medical professionals and patients. Roche was one of the first companies to bring targeted treatments to patients. In 2019, Roche had over 100,000 employees worldwide, and generated revenue of CHF 61.5 billion.
Learn more about Roche
Size
100,920 employees
Industry
NASDAQ

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