ASSOCIATE DIRECTOR, NORTH AMERICA REGULATORY LEAD

Johnson & Johnson Innovative Medicine is recruiting for Associate Director, North America Regulatory Lead in Global Regulatory Affairs, supporting programs in the Immunology Therapeutic Area.
This position is to be located in Titusville, NJ; Raritan, NJ; Spring House, PA; or La Jolla, CA (hybrid role).
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/ For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Associate Director, Regulatory Affairs will be responsible for the development, implementation, and maintenance of North America regulatory strategies for compounds in the Immunology Therapeutic Area.
Key Responsibilities.
Responsible for the development and implementation of robust North America regulatory strategy for both large and small molecules in the Immunology Therapeutic Area.
Leads and facilitates cross functional activities related to regional strategy, including providing input on implications of regulatory strategy through participation in product-related teams.
Provides regional regulatory input to the Global Regulatory Team (GRT) and may participate in the Compound Development Team (CDT) as needed.
Serves as primary contact with Health Authorities (HA) &/or Operating Companies.
Lead and/or participate in meetings with regulatory agencies as appropriate.
Prepare company personnel for interactions with HA.
Ensures that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.
Lead and oversee the preparation of dossier content for INDs, BLA/NDA according to the strategic plan for the region and health authority commitments.
Performing critical review of submission documents to ensure compliance with regulatory requirements.
Participates in development of labeling negotiation strategies.
Provides input into strategy with respect to clinical study design.
Negotiates and manages regional post-approval commitments.
Maintain an understanding of the competitive landscape, e.
., views of HAs, regulatory precedents, labeling differences and disease area-specific issues.
Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge.
Providing input to Standard Operating Procedure documents to ensure accuracy and compliance, as appropriate.
Qualifications A Bachelor's degree and at least 8 years of health regulated industry experience, or an advanced degree (MS/PharmD or PhD) and a minimum of 6 years of health regulated industry experience.
An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required.
Therapeutic area experience in autoimmune diseases is beneficial.
Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.
Understanding of the regulatory submission and approval process is required.
Previous experience interacting with health authorities is required.
Experience critically reviewing and compiling regulatory documents is required.
A proven track record to work successfully within a collaborative team environment, build positive relationships as an individual contributor is preferred.
The ability to effectively prioritize assignments for multiple products and projects simultaneously is preferred.
Excellent oral and written communication skills, as well as strong organization and multi-tasking skills are preferred.
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.
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.
· Please use the following language.
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.
areers.
nj.
om/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States.
Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.