Johnson & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Leader. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; and Raritan, NJ.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

• Responsible for the development, implementation, and maintenance of robust Global / North American/ regulatory strategies.
• Lead the Global Regulatory Team and be a key contributor on multiple cross-functional teams such as Compound Development Team (CDT).
• 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 individual will lead and/or participate in meetings with Global Health Authorities (HAs) as appropriate.
• Ensure business compliance, support due diligence activities, implement drug development strategies, and adhere to regulatory standards.

• Serve as a member of Labeling Working Group (LWG) to build or update the Company Core Data Sheet (CCDS) and for the target label contributes to the development of local labels as appropriate.
• Provides regulatory input to clinical development programs, risk/benefit assessments, and medical affairs programs.
• Provide integrated global labeling and filing strategies for assigned projects

• Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs & supplements.
• Serve as primary point of contact for US FDA
• Lead the regulatory response team for FDA and Health Canada questions.
• Manage routine maintenance submissions, coordinate 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.

• Minimum of a Bachelor's degree in scientific discipline,
• Bachelor's degree and 10+ years proven experience OR;
• Master's degree/ PharmD and 7+ years of proven experience OR;
• PhD and 5+ years of proven experience
• Experience leading interactions with Global Health Authorities is required.
• Global regulatory experience is required for the GRL role.
• Experience in drug development including early and/or 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 oncology therapeutic area is highly preferred
• Understanding of US and EMA labelling requirements for GRL role is preferred.
• In depth knowledge of current US FDA, Health Canada (and EMA for GRL) and global regulations as they relate to overall regulatory strategy is preferred.
• Ability to work successfully as a leader and individual contributor is required.
• Project management skills, strong oral & written communication skills and organization & multi-tasking skills is required.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company's long-term incentive program.
• Employees are eligible for the following time off benefits:
  • Vacation - up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits