Director, Global Regulatory Leader

Description

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

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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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• United States - Requisition Number: R-027513

• Canada - Requisition Number: R-032876

• United Kingdom - Requisition Number: R-032879

• Belgium, Netherlands - Requisition Number: R-032880

• Switzerland - Requisition Number: R-032883

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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 Beerse, Belgium or Leiden, Netherlands.

The Director, Global Regulatory Leader will be responsible for the development, implementation and maintenance of robust global regulatory strategies for select projects spanning the same target disease areas.

Principal Responsibilities:

• 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 aligned with product portfolio, regional strategies, CMC (Chemistry, Manufacturing, and Controls)-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned).

• In interacting with the Health Authorities, lead and/or participate in meetings with FDA, Health Canada, EMEA 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.

• Serve as a member of Labeling Working Group (LWG) to create or update the Company Core Data Sheet (CCDS) and contribute to the development of local labels as appropriate. Provide regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label.

• Provide integrated global labeling and filing strategy for assigned projects

Qualifications:

• A minimum of a Bachelor’s degree in a scientific discipline is required. An advanced degree (Master’s Ph.D, PharmD.) in a scientific discipline is preferred.

• A minimum of 10 years of overall regulatory experience with a Bachelor’s degree; a minimum of 7 years of overall regulatory experience with a Master’s or PharmD degree; or a minimum of 5 years of overall regulatory experience with a Ph.D. is required.

• Global regulatory experience is required.

• Experience leading interactions with Health Authorities is required.

• A broad understanding and experience in drug development, including early and late development is required.

• A broad understanding of lifecycle management is required.

• In depth knowledge of current U.S. FDA, EMEA, Health Canada and global regulations as they relate to the overall regulatory strategy is required.

• Working knowledge of U.S. and/or global labeling requirements is preferred.

• Experience in the Neuroscience therapeutic area is preferred.

• Experience managing a portfolio of multiple products is preferred.

• Project management skills required.

• Must have excellent oral and written communication skills.

• Must have strong organizational, time management and multi-tasking skills.

• Must have effective critical thinking and problem-solving skills.

• The ability to exercise independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel solutions is required.

• The ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment is required.

• The ability to collaborate successfully in a matrixed environment as a leader and individual contributor is required.

• This position will require up to 10% travel.

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