Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Director, North American/ Global Regulatory Leader (US Regulations Focused). The position can primarily be located in Spring House, PA; Raritan, NJ, Chesterbrook/Malvern PA. Remote work options may be considered on a case-by-case basis and if approved by the Company (in the US or EU).

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.

The Director, North American/ Global Regulatory Leader, is responsible for the development, implementation and maintenance of North American regulatory strategies. The Director is also responsible for global regulatory strategies for select projects spanning the same target disease areas.

ESSENTIAL FUNCTIONS:

• Responsible for the development, implementation and maintenance of robust North American regulatory strategies.
• Be a key contributor/leader on the Global Regulatory Team and on multiple cross-functional teams.
• Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.
• Ensure that regulatory strategies are in alignment with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned).
• In interacting with the Health Authorities, the NA/GRL will lead and/or participate in meetings with FDA, Health Canada, and other Health Authorities (HAs) as appropriate.
• Develop a regulatory strategy that will deliver global and/or regional needs with initial focus on the key markets identified.
• Ensure business compliance, and implementation of and adherence to regulatory standards.

In NARL role:

• Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs as well as addendums & supplements.
• Lead the regulatory response team for FDA and Health Canada questions.
• Manage routine maintenance submissions, manage & track NA post-approval commitments, provide input and review submission documents, as well as approves submissions before dispatching to regulatory authorities
• Contributes to the development of the USPI, lead the development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as well as reviews FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct.

Qualifications

• Minimum of a Bachelor’s degree in scientific or equivalent discipline is required, Advanced Degree preferred (MS, PhD, PharmD)
  • Bachelor’s degree and 10+ years overall experience (8+ years pharma, regulatory experience, etc.) OR;
  • Master’s degree/ PharmD and 7+ years of overall experience, OR;
  • PhD and 5+ years of overall experience
• Experience leading interactions with Health Authorities is required.
• Global regulatory experience is preferred.
• A broad understanding and experience in drug development including early and late development, as well as a broad understanding of lifecycle management is required.
• Ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment is required.
• Previous experience in the therapeutic area is highly preferred.
• Working knowledge of US and/or Global labelling requirements is preferred.
• In depth knowledge of current US FDA, Health Canada and global regulations as they relate to overall regulatory strategy is preferred.
• Experience managing a portfolio of multiple products is preferred.
• Project management skills, strong oral & written communication skills and organization & multi-tasking skills is required.
• Strong leadership capabilities and ability to work successfully in a matrixed environment is required.
• Exercises strong organizational and time management skills is required.
• Exercises independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel solutions is required.
• Demonstrated ability of strategic thinking and contingency planning with respect corporate objectives is required.
• Effective critical thinking including problem solving and goal setting for improved efficiencies is required.
• Strong collaboration skills, including effective communication and conflict resolution skills is required.

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 .

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.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $175,375 to $302,852.

The anticipated base pay range for this position in all other US locations is $152,500 - $263,350.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits