DIRECTOR, NORTH AMERICAN REGULATORY LEADER (NARL)

Janssen Research & Development, L.
.
., a division of Johnson & Johnson's Family of Companies is recruiting for a Director, North American Regulatory Leader (NARL) located 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.
nj.
om/.
The Director, North American Regulatory Leader, is responsible for the development, implementation and maintenance of North American regulatory strategies.
The Director also supports global regulatory strategies for select projects spanning the oncology therapeutic area.
Key Responsibilities.
Lead the North America 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 Health Authority submissions such as INDs, 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.
Develop a regulatory strategy that will deliver North America needs and align with global development plans.
Ensure business compliance, support due diligence activities, implement drug development strategies and adhere to regulatory standards.
Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs as well as addendum & supplements.
Serve as primary point of contact for US FDA.
Lead the regulatory response team for FDA and Health Canada questions.
Ensure U.
.
Business Partners are consulted and provided input into U.
.
regulatory strategies, post market requirements (PMR) fulfillments, and other U.
.
related issues.
Manage routine maintenance submissions, lead & track NA post-approval commitments, provide input and review submission documents, as well as approve submissions before dispatching to regulatory authorities.
Contribute to the development of the USPI, lead the development of NA labeling negotiation strategies, and development of supporting documentation for labeling, as well as reviews FDA and Health Canada labeling to ensure consistency with the CCDS and ensure that annotations are complete and accurate.
Qualifications Education.
Bachelor's degree with 7+ years of proven experience OR Master's degree with 5+ years of proven experience OR PharmD/Ph.
.
with 4+ years of proven experience in Life Sciences, Law or an equivalent subject area is required.
Experience and Skills.
Required.
Experience leading interactions with Health Authorities is required.
A broad understanding and experience in drug development including early and late development, as well as lifecycle management is required.
Ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment is required.
Solid understanding of U.
.
labeling requirements is required.
In depth knowledge of current US FDA and Health Canada and global regulations as they relate to overall regulatory strategy is required.
Ability to work successfully in an environment as a leader and individual contributor is required.
People and project management skills, strong oral & written communication skills and organization & multi-tasking skills are required.
Preferred.
Previous experience in the therapeutic area and/or advanced therapy modality is highly preferred.
Experience leading a portfolio of multiple products is preferred.
Other.
Exercise independent judgment and execution in anticipating, interpreting, evaluating and resolving complex organization issues with novel solutions.
Display a willingness to challenge status quo and be a refiner Encourage and adopts input from broad range of collaborators to bring together different perspectives.
Identify and enhances business/work processes to embed an environment of innovation to remain driven.
Solicit acceptance of new ideas, practices and approaches from functional groups within J&J and parties outside J&J through business/regulatory leadership; influences significant change.
Collaborate and influences outcomes with those with both shared and divergent interests within company, function, or externally.
May represent J&J or company externally.
Cultivate and demonstrates networks and partnerships.
The anticipated base pay range for this position is $ to $.
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.
Additional information can be found through the link below.
For additional general information on Company benefits, please go to.
https://www.
areers.
nj.
om/employee-benefits.
This job posting is anticipated to close on .
The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om 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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.