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Director, Global Regulatory Leader (GRL) (1 of 2) - 2406184564W

Description

Johnson & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Affairs Leader (1 of 2) located in New Jersey or Pennsylvania.

At 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 collaborate with the world for the health of everyone in it. Learn more at www.janssen.com .

Key Responsibilities:

• Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with Health Authorities globally 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.

• Be responsible for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in neuroscience/neuropsychiatry in different phases of development

• 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 ensures strategy is in alignment with regional teams, 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)

• Lead the preparation of regulatory dossiers for submissions to US FDA.

• Lead the preparation and participate in meetings with Health Authorities (HAs) in US and OUS markets.

• Serve as a member of the Labeling Working Group to create or update the CCDS and contribute to the development of local labels as appropriate.

• Provides 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

• 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.

Qualifications

Education:

• A Bachelor’s degree in a scientific field or Advanced degree (MS, PhD, MD or Pharm D) (preferred)

Experience and Skills:

Required:

• A minimum of 8 years’ experience in either pharmaceutical industry, medical device industry, consumer industry or health authority regulated industry

• At least 6 years of Regulatory Affairs experience required with focus on the NA region and FDA

• Experience establishing productive working relationships with Health Agencies and gaining a deep understanding of how they view certain drug development issues

• Solid understanding of WW HA laws (with a focus on FDA), regulations, guidances 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

• 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.

Preferred:

• Experience or training in Neuroscience or more specifically, Neuropsychiatry.

• Organization and Talent Development: A proven track record of encouraging the long-term learning or development of others.

Other:

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

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 $157,000 - $271,400.

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.careers.jnj.com/employee-benefits

Primary Location NA-US-New Jersey-Titusville

Other Locations NA-US-Pennsylvania, NA-US-New Jersey

Organization Janssen Research & Development, LLC (6084)

Job Function Regulatory Science

Req ID: 2406184564W