Director, Regulatory Policy and Intelligence

05 Sep, 2022

Jobs

Director, Regulatory Policy and Intelligence

Johnson & Johnson
Rockville, MD

Job Description

Janssen Research and Development, LLC., is recruiting for a Director, Global Regulatory Policy and Intelligence in Rockville, MD or Remote work options may be considered, on a case-by-case basis, and if approved by the Company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.  Janssen Research & Development, LLC., is part of the Janssen Pharmaceutical Companies.

Job Summary:

  • Identifying regulatory and legislative issues, trends, and changes that have the potential to impact the development and marketing of J&J’s pharmaceutical products.
  • Providing high quality strategic input and tactical support to global product teams throughout the product lifecycle, with the goal of empowering informed decision-making to bring products to market and maintain their availability for patients.
  • Partnering with global or regional subject matter experts and groups including Local Operating Companies to engage in direct regulatory advocacy and influencing activities relating to regulatory policies.
  • Actively engaging in Trade Association initiatives, Health Authority policy-focused meetings, and consultation and contribution to global pharmaceutical commenting efforts.
  • Acting in a key liaison role with the Janssen US regulatory community, supporting US regional regulatory affairs and compound development with focused regulatory strategy support for FDA interactions, product development, and submissions to FDA.

Key Responsibilities:

  • A minimum of 10 years of relevant pharmaceutical policy and regulatory experience, including 5 years internal FDA experience preferred.
  • Support J&J in interactions with FDA and other regional health authorities on advocacy issues, enhancing and fostering relationships with key decisions makers in policy and legislative area A minimum of 10 years of relevant pharmaceutical policy and regulatory experience, including 5 years internal FDA experience preferred.
  • Leverage insider status to gain insight and intelligence in the US.
  • Lead and develop effective approaches to global, regional, or US regulatory policy activities, including generating positions, influencing plans, tracking, and internally communicating.
  • Participate in identifying, defining, and implementing influencing strategies, partnering with project teams, subject matter experts, Government Affairs, Legal and Local Operating Companies.
  • Develop effective approaches to, and participate in, Trade Association initiatives, health authority meetings, and consultations.
  • Coordinate input into commenting on regulatory or legislative texts to help shape and influence key regulatory policies.
  • Provide feedback to all J&J pharmaceutical companies and relevant personnel on current regulatory guidelines and procedures as well as emerging regulatory/legislative issues that impact J&J pharma businesses or products.
  • Represent J&J at key trade association and agency meetings in collaboration with local, regional, or global regulatory leaders to carry out tactical operations in the representation of J&J’s external regulatory policy strategy.
  • Monitor US regulatory environment; evaluate potential impact on product development and approval.
  • Interpret Agency statements and actions, including FR Notices and Guidance for Industry, for greater understanding by J&J teams and community.
  • Utilize FDA insider status by liaising directly with Agency management and staff and gaining access to the Agency for J&J; drive management meetings with FDA officials.
  • Manage resolution of critical FDA-related issues.
  • Answer general FDA questions and serve as point of contact for the Agency.
  • Provide advice and guidance on the development of regulatory strategies for drug development and communicating with FDA, ensuring strategic alignment and management of regulatory issues.
  • Provide advice and guidance on achieving successful FDA meetings, including strategy for key FDA meetings and communication of key meeting outcomes to management.
  • Leverage and communicate lessons learned across teams, therapeutic areas, and business units.
  • Support internal functions and/or groups through consultation and training on specific regulatory intelligence issues.
  • Collect, organize, and manage critical regulatory intelligence information to enable easy distribution or access across all businesses in a way that best serves an advantage. This includes the support of increased use of regulatory intelligence and policy across all businesses in the development of effective strategies and decision-making.
  • Collaborate and partner with GRPI Intelligence & Knowledge management to ensure effective and timely dissemination of regulatory information and intelligence.
  • Drive the provision of US and regional expertise to the impact assessment of regulatory developments in the external environment.

Qualifications

Experience and Skills:

Education:

  • A Bachelor’s degree with minimum of 8 years regulatory policy or advocacy experience (required)
  • Master’s degree with minimum 6 years regulatory policy or advocacy experience (preferred)

Required:

  • A minimum of 10 years of relevant pharmaceutical policy and regulatory experience
  • Must have expert knowledge about FDA, FDA staff, and FDA policies. Must also have a broad and thorough understanding of the Federal Food, Drug, and Cosmetic Act and its implementing regulations.
  • Must have the ability to analyze new regulations or policies and assess the impact on the J&J pharmaceutical business or development programs.
  • Excellent oral and written communication skills

Preferred:

  • Experience with regulatory policy pertaining to digital health or real-world evidence
  • Five years of internal FDA medical product experience
  • 5 years internal FDA experience

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.

The anticipated base pay range for this position is $152, 500 to $229,000. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.

Learn more here

Job posted: 2022-09-05