Director, Global Regulatory Leader

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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

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

Remote work options may be considered on a case-by-case basis and if approved by the Company and will be available in all states within the United States.  While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application.  We invite candidates from any location to apply.

The Director, Global Regulatory Leader in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of global regulatory strategies for investigational rare disease and advanced cell therapy products supporting programs in the Immunology Therapeutic Area.

Principal Responsibilities:

• As the global regulatory lead for assigned projects, develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area.  Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market access plans.

• Serve as the key regulatory point of contact, providing leadership and guidance across cross-functional teams to support successful development and commercialization, including providing input on implications of regulatory strategy through participation in product-related teams.

• Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed.

• Lead and/or participate in meetings with regulatory agencies as appropriate and prepare company personnel for interactions with Health Authorities (HAs).  Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.

• Lead and oversee key health authority documents (e.g., IND/CTA, meeting requests, briefing packages, responses, marketing applications) according to the strategic plan for the region and health authority commitments. Perform critical review of submission documents to ensure compliance with regulatory requirements.

• Negotiate and manage regional post-approval commitments and global label expansion strategies.

• Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues) and provide proactive strategic regulatory advice to project teams and global regulatory teams.

• Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge and provide strategic regulatory input into clinical trial designs, labeling, risk management, and development programs to meet global and regional requirements.

• Support due diligence and business development assessments.

• Identify and resolve regulatory issues that may affect projects or organizational objectives.

 

Qualifications:

• A minimum of a Bachelor’s degree is required, preferably in a scientific or technical discipline.  Advanced degree (Master’s,