Regulatory Policy Program Analyst

Washington DC
District of Columbia, United States of America


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The Position

Regulatory Policy is part of the broader Product Development Regulatory (PDR) organization that interprets the needs of worldwide health authorities and provides strategic information necessary to advance Roche’s development and business priorities. PDR policy is committed to developing regulatory frameworks that are evidence-based, innovative, ethical, and influential in the industry.  Regulatory Policy Program Analysts are assigned their responsibilities by varying projects, as business needs dictate, and often perform work that transcends multiple or all therapeutic areas. Regulatory Policy Program Analysts work in close coordination with other members of the policy team and under the supervision of their manager. They project manage implementation of regulatory policy strategies based on regulatory and legislative trends important to Roche’s product portfolio. Regulatory Policy Program Analysts work to support planning regulatory and advocacy positions and facilitate engagement with regulators and KOLs on key topics of interest. Regulatory Policy Program Analysts support and participate in activities with trade associations, think tanks, advocacy organizations and regulatory authorities. They are also responsible for identifying, documenting, coordinating and communicating regulatory policy activities and information. 

EXAMPLE DUTIES AND RESPONSIBILITIES: 

  • Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics 
  • Obtains and applies in-depth knowledge of regulatory guidelines, procedures and best practices 
  • Writes, coordinates, analyzes and/or reviews comments on regulatory or legislative initiatives and guidance 
  • Supports interactions on policy and advocacy issues, including building relationships with key regulatory decision-makers 
  • Supports implementation of strategic and tactical plans to initiate regulatory changes/evolutions 
  • Project manages implementation of regulatory policy strategies by developing workplans, coordinating stakeholder outreach, synthesizing input from SMEs, managing communications and liaising with contractors and vendors as needed.
  • Analyzes the regulatory environment. Communicates specific regulatory trends, analysis and intelligence to various internal functions.
  • As needed or otherwise appropriate, may be required to analyze impact of other policy areas including regional and international policy.
  • Works with external vendors to conduct, coordinate and communicate regulatory policy information and trends to internal functions and teams 

QUALIFICATIONS & EXPERIENCE: 

  • Bachelors Degree required (life sciences, law or public policy disciplines strongly preferred) 
  • Advanced Degree in related field is preferred 
  • Average of 3 or more years’ work experience 
  • Average of 2 or more years’ relevant regulatory or health care policy experience
  • Demonstrated competence in regulatory policy and intelligence 
  • Demonstrated ability to analyze regulatory and legislative documents
  • Demonstrated understanding of FDA guidelines 
  • Demonstrated program management skills
  • Ability to multi-task and work in a team environment
  • As required, ability to travel

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Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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