Associate Director, Regulatory Affairs, North American Regional 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

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  
 

We are searching for the best talent for an Associate Director, Regulatory Affairs, North American Regional Leader (NARL) to be located in Spring House, PA or Raritan, NJ.

Purpose: The Associate Director, Regulatory Affairs, North American Regional Leader, is responsible for North American and global regulatory strategies for select projects spanning the oncology therapeutic area. This role supports the initiatives for the Interventional Oncology group (INTO). The position will focus on a range of novel product solutions to deliver solutions to treat cancers directly into the tumor.

You will be responsible for:

• 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.
• Key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approvals.
• 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.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).
• Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents.
• Collaborate with cross-functional submission delivery teams.
• Participate and coordinate Health Authority interactions by leading regulatory team members and cross-functional team members.
• Ability to flex across different product types (pharma, devices, combo products).
• Intellectual curiosity and ability/flexibility in learning new things and working in novel areas with limited regulatory precedence. This role will include an opportunity to flex across different product types (pharma, devices, combo products).
   

Qualifications/Requirements:

• Minimum of a Bachelor’s degree in scientific or equivalent discipline
  • Bachelor’s degree plus 8+ years relevant experience OR;
  • Master’s degree/ PharmD plus 6+ years relevant experience, OR;
  • PhD plus 4+ years relevant exp