Associate Director, North America Regulatory Leader

Johnson and Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, North America Regulatory Leader in Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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/.

• Key contributor to regulatory strategy plan, regulatory submission strategy, identifying submission risks, mitigations and opportunities, while leading regulatory applications and managing procedures through approvals.
• Develop, execute and oversee submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with US FDA and Health Canada Agency to find the best development strategies for novel therapies in the areas where no other precedents exist.
• Understand the regulatory framework, including regional trends, for various types of applications and provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities (US FDA, Health Canada) for assigned deliverable(s).
• Integrate inputs from regional and functional Global Regulatory Team members including input from external partnership for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in cardiovascular in different phases of development.
• Provide strategic regulatory input to key development documents, including clinical protocols, statistical analysis plan, clinical and nonclinical reports and summary documents.
• Drive the execution of regulatory plan for select health authority submissions and projects through close collaboration with multiple functional areas.
• In collaboration with the global regulatory team, develop global submission plans and Health Authority interaction plans.
• Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective
• Build and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensures strategy is in alignment with NA regional teams, CMC, labeling, commercial strategies, and the Target Product Profile.
• Serve as a member of the Labeling Working Group, Clinical Teams, joint teams or joint Cross-Functional teams with external partner(s).
• Serve as primary point-of-contact to Health Authority
• Ensure compliance with internal and external policies and legislation
• Support or lead Due Diligence activities as appropriate
• Results and Performance Driven/Initiative: Assumes personal ownership and accountability for business results and solutions; you can easily identify a problem, obstacle or opportunity and act to address current or future problems or opportunities.

• Minimum of a Bachelor's degree in a scientific field (required)
• Advanced degree (MS, PhD, MD or Pharm D) (preferred)

• A minimum of 8 years' experience in either pharmaceutical industry, medical device industry, consumer industry or health authority regulated industry
• At least 3 years of Regulatory Affairs experience required with focus on the NA region and FDA
• At least 2 years' experience within a supervisory capacity or managing teams within a matrix environment
• Experience establishing productive working relationships with FDA/CDER and gaining a deep understanding of how the FDA views certain drug development issues, particularly cardiovascular products.
• Solid understanding of WW HA laws (with a focus on FDA), regulations, guidance and regulatory submission routes available for new study drugs
• Ability to maintain knowledge of competitors in the therapeutic area and what they are doing in early/late development and knowledge of labeling aspects.
• Organization and Talent Development: A proven track record of encouraging the long-term learning or development of others.
• Impact and Influence: Able to persuade, convince, or influence others, to gain commitment on an idea or a course of action.
• Organization Awareness: Understands the power relationships in one's own organization and in other organizations.
• Self-Awareness and Flexibility: Keeps emotions in check and acts professionally under stressful conditions; puts the interests of the enterprise above their own; can adapt to, and work effectively within a variety of situations, and with various individuals or groups.
• Strategic and Conceptual Thinking: Driven to envision a better future; take any role or job and makes it better. Able to identify key or underlying issues in sophisticated situations.

• Experience in cardiovascular and/or mega-trials

• This position may require approximately 10% travel, both International and Domestic.

• 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)).
• 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