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Associate Director, Regulatory Policy & Intelligence.

Company: Johnson & Johnson
Location: Titusville
Posted on: November 22, 2021

Job Description:

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Policy & Intelligence. The position will be based in Rockville, MD; Spring House, PA; Titusville, NJ; or Raritan, NJ, with possibility for remote work.

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.

Key Responsibilities of the Associate Director, Regulatory Policy & Intelligence:
Identify regulatory and legislative issues, trends, and changes that could impact the development and marketing of pharmaceutical products.
Partner with global and regional subject matter experts and groups including Government Affairs to engage in direct legislative and regulatory advocacy and influencing activities.
Actively engage in Trade Association initiatives, Health Authority policy-focused meetings, and global pharmaceutical commenting efforts on legislation, regulations, guidance, and other regulatory policies.
Liaison 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, including by interpreting Agency statements and actions and providing advice and guidance on achieving successful FDA outcomes.
Provide intelligence and knowledge management support to ensure effective and timely dissemination of regulatory information and intelligence.

Qualifications
A minimum of a bachelor's degree is required, advanced degree preferred.
A bachelor's degree with minimum of 8 years related experience or Advanced degree with 6 years of related experience
Drug development experience is preferred
Pharma industry experience is preferred
Experience advocating externally to shape the regulatory environment highly preferred.
Understanding about FDA, FDA staff and FDA medical product policies is required
Must have the ability to analyze new regulations or policies and assess the impact on the J&J pharmaceutical business or development programs.
Experience in rare and orphan drug development, Digital R&D, Real world evidence is preferred.
Up to 10% travel may be required
Remote work options may be considered on a case-by-case basis and if approved by the Company

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.

Primary Location

United States-Maryland-Rockville-1700 Rockville Pike, Suite 445

Other Locations

North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, North America-United States

Organization

Janssen Research & Development, LLC (6084)

Job Function

Regulatory Affairs

Requisition ID

2105977288W

Keywords: Johnson & Johnson, Trenton , Associate Director, Regulatory Policy & Intelligence., Executive , Titusville, New Jersey

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