Associate Director, Regulatory Affairs

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs. This position can be located in Titusville, NJ; Raritan, NJ; or Spring House, PA. Remote work options within the United States may be considered on a case-by-case basis and if approved by the company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.

The Associate Director, Regulatory Affairs will be accountable for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in pulmonary hypertension in different phases of development.

Principal Responsibilities:

• Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist.
• Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent and unified regional regulatory strategies.
• Drive the execution of regulatory plan for select projects through close collaboration with multiple functional areas.
• Build and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensure strategy is in alignment with NA regional teams, Chemistry, Manufacturing, and Controls (CMC), commercial strategies, and the Target Product Profile.
• Ensure that regulatory strategies also consider non-regulatory market access issues (e.g., health technology assessments, payor demands).
• Own the preparation of regulatory dossiers for submissions to U.S. and Canada.
• Lead the preparation for and participate in meetings with Health Authorities (HAs) in the U.S. and Canada.
• Serve as a member of the Labeling Working Group 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.
• Ensure compliance with internal and external policies and legislation.
• Support or lead Due Diligence activities as appropriate.
• Assume personal ownership and accountability for business results and solutions; identify problems, obstacles or opportunities and act to address current or future problems or opportunities.

• A minimum of a Bachelor's degree in a scientific or technical discipline is required. Advanced degree (Master's, PhD, PharmD or MD) strongly preferred.
• A minimum of 8 years of experience in the pharmaceutical, medical device, consumer or health authority regulated industry is required.
• A minimum of 3 years of Regulatory Affairs experience with focus on the North America region and FDA is required.
• A minimum of 2 years of experience in a supervisory capacity or managing teams within a matrix environment is required.
• Experience with strategic clinical drug development is required.
• Experience establishing productive working relationships with FDA/Center for Drug Evaluation and Research (CDER) and understanding of how the FDA views certain drug development issues is required.
• Solid understanding of Worldwide Health Authority laws (with a focus on FDA), regulations, guidances, and regulatory submission routes available for new study drugs is required.
• Experience in the Pulmonary Hypertension Therapeutic Area is preferred.
• Must have excellent communication and interpersonal skills.
• Must have strong analytical and problem resolution skills.
• Must have strong leadership skills with a proven track record of encouraging long-term learning and development of others.
• The ability to maintain knowledge of competitors in the therapeutic area, including labeling aspects and what they are doing in early/late development, is required.
• The ability to collaborate effectively with all levels and influence decision-making across a matrix organization is required.
• This position will require up to 10% domestic and international travel.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $166,000 to $267,145.

The anticipated base pay range for this position in all other U.S. locations is $135,000 to $232,300.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.

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
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on February 8, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.