Associate Director, North America Regulatory Leader

Johnson & Johnson Innovative Medicine; Lower Gwynedd Township (Montgomery County); On-site; USD 137,000 - 236,000; Full time

Job summary

Join a forward-thinking company as an Associate Director in Regulatory Affairs, leading the charge in developing innovative strategies for Immunology treatments. This pivotal role involves collaborating with cross-functional teams and engaging with regulatory authorities to ensure compliance and successful product development. With a focus on patient-centered solutions, you will play a crucial part in shaping the future of healthcare. If you are passionate about making a difference and possess the expertise in regulatory processes, this is the perfect opportunity for you to thrive in a dynamic environment.

Benefits

Health Insurance

Retirement Plans

Paid Time Off

Performance Bonuses

Qualifications

• 8+ years of experience in a regulated health industry.
• Strong understanding of FDA and ICH regulations.

Responsibilities

• Develop and implement regulatory strategies for Immunology.
• Lead interactions with Health Authorities and manage submissions.
• Ensure compliance in dossier preparation for regulatory documents.

Skills

Regulatory Strategy Development

Cross-Functional Leadership

Regulatory Submissions

Communication Skills

Organization Skills

Multitasking Skills

Education

Bachelor's Degree

Master's Degree

PharmD

PhD

Job description

Join to apply for the Associate Director, North America Regulatory Leader role at Johnson & Johnson Innovative Medicine

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

Position Overview

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.

Responsibilities

1. Develop and implement North America regulatory strategies for large and small molecules in Immunology.
2. Lead cross-functional activities related to regional strategy, including providing input on regulatory implications.
3. Provide regional regulatory input to the Global Regulatory Team and participate in the Compound Development Team as needed.
4. Serve as primary contact with Health Authorities and/or Operating Companies.
5. Lead or participate in meetings with regulatory agencies.
6. Prepare personnel for interactions with Health Authorities.
7. Ensure timely responses to FDA questions and align with product strategy.
8. Oversee dossier preparation for INDs, BLAs/NDAs, ensuring compliance.
9. Review regulatory documents for compliance.
10. Participate in labeling negotiation strategies.
11. Contribute to clinical study design strategies.
12. Manage regional post-approval commitments.
13. Maintain awareness of the competitive landscape and regulatory environment.
14. Stay updated on laws, guidances, and requirements related to autoimmune diseases and general regulatory issues.
15. Contribute to SOP development to ensure accuracy and compliance.

Qualifications

• Bachelor’s degree required; Master’s, PharmD, or PhD preferred.
• At least 8 years of experience in a regulated health industry.
• Understanding of drug lifecycle, FDA and ICH regulations, and regulatory processes.
• Experience with regulatory submissions and interactions with authorities.
• Experience in reviewing regulatory documents.
• Experience in autoimmune diseases is a plus.
• Strong communication, organization, and multitasking skills.

Compensation and Benefits

The base pay range is $137,000 to $235,750, with performance bonuses and comprehensive benefits including health insurance, retirement plans, and paid time off. Additional details available at https://www.careers.jnj.com/employee-benefits.

Additional Information

This role is full-time, based in the specified locations, and is eligible for various employee benefits. The application deadline is 04/18/2025, but the posting may be extended.

Equal Opportunity Statement

Johnson & Johnson is an Equal Opportunity Employer. We value diversity and inclusion and encourage all qualified candidates to apply. Accommodations are available for applicants with disabilities upon request.