Associate Director, North America Regulatory Leader

Johnson & Johnson; North Carolina; Hybrid; USD 137,000 - 236,000; Full time

Job summary

A leading healthcare company is seeking an Associate Director, North America Regulatory Leader to develop regulatory strategies for Immunology. The role involves cross-functional leadership and direct interaction with health authorities, ensuring compliance and timely responses to regulatory inquiries.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation Time

Sick Time

Qualifications

• Minimum 8 years in health regulated industry.
• Experience with FDA and ICH Regulatory requirements.

Responsibilities

• Develop North America regulatory strategy for Immunology.
• Lead meetings with Health Authorities.
• Prepare dossier content for submissions.

Skills

Communication

Organization

Multi-tasking

Education

Bachelor's Degree

Master’s Degree

PhD

Job description

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:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

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

We are searching for the best talent for an Associate Director, North America Regulatory Leader to be located in Spring House, PA; Raritan, NJ; or Titusville, NJ.

Purpose: The Associate Director, Regulatory Lead in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of North America regulatory strategies for compounds supporting programs in the Immunology Therapeutic Area.

You will be responsible for:

• Developing and implementing robust North America regulatory strategy for both large and small molecules in the Immunology Therapeutic Area.
  
• Leading and facilitating cross functional activities related to regional strategy, including providing input on implications of regulatory strategy through participation in product-related teams.
  
• Providing regional regulatory input to the Global Regulatory Team (GRT) and may participate in the Compound Development Team (CDT) as needed.
  
• Serving as primary contact with Health Authorities (HA) and/or Operating Companies.
  
• Leading and/or participating in meetings with regulatory agencies as appropriate.
  
• Preparing company personnel for interactions with HA.
  
• Ensuring that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.
  
• Leading and overseeing the preparation of dossier content for INDs, BLAs/NDAs according to the strategic plan for the region and health authority commitments.
  
• Performing critical review of submission documents to ensure compliance with regulatory requirements.
  
• Participating in development of labeling negotiation strategies.
  
• Providing input into strategy with respect to clinical study design.
  
• Negotiating and managing regional post-approval commitments.
  
• Maintaining an understanding of the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues.
  
• Maintaining 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 / Requirements:

Education:

• A minimum of a bachelor's degree is required. An advanced degree (Master’s, PharmD or PhD) is preferred.

Experience and Skills:

Required:

• A minimum of 8 years of health regulated industry experience is required.
  
• An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required.
  
• 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.

Preferred:

• Therapeutic area experience in autoimmune diseases is beneficial.
  
• 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.

The anticipated base pay range for this position is $137,000 to $235,750.

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. https://www.careers.jnj.com/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.

This job posting is anticipated to close on 04/18/2025. 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 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 ([e-mail]) or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

The anticipated base pay range for this position is :

The anticipated base pay range for this position is $137,000 to $235,750.

Additional Description for Pay Transparency: