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:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America, US026 PA Spring House - 1400 McKean Rd

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

Remote work options may be considered on a case-by-case basis and if approved by the Company.

We are searching for the best talent for Director, North American Regional Leader/Global Regulatory Leader to be in Titusville, NJ; Raritan, NJ; Spring House, PA; Horsham, PA; or any East Coast J &J location.

Purpose: The Director, North American Regional Leader/Global Regulatory Leader, is responsible for North American and global regulatory strategies for select projects spanning the oncology therapeutic area.

You will be responsible for:

Essential functions: Roles:

• Responsible for the development, implementation, and maintenance of robust Global / North American/ regulatory strategies.

• Lead the Global Regulatory Team and be a key contributor on multiple cross-functional teams such as Compound Development Team (CDT).

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

• In interacting with the Health Authorities, the individual will lead and/or participate in meetings with Global Health Authorities (HAs) as appropriate.

• Ensure business compliance, support due diligence activities, implement drug development strategies, and adhere to regulatory standards.

In NARL role:

• 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.

• 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.

In GRL role leading the Global Regulatory Team (GRT):

• Serve as a member of Labeling Working Group (LWG) to build or update the Company Core Data Sheet (CCDS) and for the target label contributes to the development of local labels as appropriate.

• Provides regulatory input to clinical development programs, risk/benefit assessments, and medical affairs programs.

• Provide integrated global labeling and filing strategies for assigned projects

Qualifications / Requirements:

• Minimum of a Bachelor’s degree in scientific discipline,

• Bachelor’s degree and 10+ years proven experience OR;

• Master’s degree/ PharmD and 7+ years of proven experience OR;

• PhD and 5+ years of proven experience

Must haves:

• Experience leading interactions with Health Authorities is required.

• FDA and Global regulatory experience is required.

• In depth knowledge of current US FDA regulations is absolutely required.

• Experience in drug development including early and/or late development, as well as a broad understanding of lifecycle management is required.

• Ability to flex across different product types (pharma, devices, combo products) is required.

• Therapeutic area experience in oncology is required.

• Experience with companion diagnostics, combination products and/or biomarker development, or medical device is beneficial.

• Intellectual curiosity and ability/flexibility in learning new things and working in novel areas with limited regulatory precedence is required. This role will include an opportunity to flex across different product types (pharma, devices, combo products).

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

• Ability to work successfully as a leader and individual contributor is required.

• Project management skills, strong oral & written communication skills and organization & multi-tasking skills is required.

• Knowledge of Health Canada (and EMA for GRL) and other global regulations as they relate to overall regulatory strategy is highly preferred.

• Understanding of US and EMA labelling requirements for GRL role is preferred.

• Strong organizational and time management skills.

• Strong collaboration skills, including effective communication and conflict resolution skills.

• Strong leadership capabilities and ability to work successfully in a matrixed environment.

• Effective critical thinking, including problem solving and goal setting.

• Demonstrated ability to think strategically and contingency plan in order to meet business objectives.

• 10% domestic travel and potential international travel will be required for this position.

The anticipated base pay range for this position is 160000 to 276000.

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

Additional information can be found through the link below.

http://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

Additional Description for Pay Transparency:

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.