Director, North America Regulatory Leader (Oncology)
Apply NowCompany: Johnson and Johnson
Location: Spring House, PA 19477
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:
People Leader
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 a Director, North America Regulatory Leader (Oncology) to be in Raritan, NJ; Titusville, NJ; or Spring House, PA.
Purpose:
The Director, North American Regulatory Leader, is responsible for the development, implementation and maintenance of North American regulatory strategies.
You will be responsible for:
The development, implementation and maintenance of robust North American/ regulatory strategies.
Leading the North America discussions during the Global Regulatory Team and be a key contributor on multiple cross-functional teams such as Compound Development Team (CDT).
Providing strategic direction to the teams and critical review of key Health Authority submissions such as IND/NDA/BLAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.
Ensuring that NA regulatory strategies are in alignment with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile
Interacting with the Health Authorities, the NARL will lead and/or participate in meetings with FDA, Health Canada, and other Health Authorities (HAs) if appropriate.
Developing a regulatory strategy that will deliver global and/or regional needs with initial focus on the key markets identified.
Ensuring business compliance, support due diligence activities, implement drug development strategies and adhere to regulatory standards.
Establishing North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs as well as addendums & supplements.
Serving as primary point of contact for US FDA
Ensuring US Business Partners are consulted and provided input into US regulatory strategies, PMR fulfillments, and other US-related issues.
Leading the regulatory response team for FDA and Health Canada questions.
Managing routine maintenance submissions, manage & track NA post-approval commitments, provide input and review submission documents, as well as approves submissions before dispatching to regulatory authorities
Contributing to the development of the USPI, lead the development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as well as reviews FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct.
Engaging in TA and department workstreams and initiatives to lead scientific innovation and process improvements/efficiencies.
Qualifications / Requirements:
Education:
Minimum of a Bachelor's degree in scientific or equivalent discipline is required
Advanced Degree (MS, PhD, PharmD) is preferred
Required:
Minimum of 10-12 years of relevant work experience
Experience leading interactions with Health Authorities
Broad understanding and experience in drug development, including early and late development, as well as a broad understanding of lifecycle management.
Ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment.
Working knowledge of US labelling requirements.
In depth knowledge of current US FDA, Health Canada and/or global regulations as they relate to overall regulatory strategy.
Experience managing a portfolio of multiple products.
Ability to work successfully in a matrixed environment as a leader and individual contributor.
People and project management skills, strong oral & written communication skills and organization & multi-tasking skills.
Preferred:
Previous experience in the oncology therapeutic area and/or advanced therapy modality
The anticipated base pay range for this position in the US is $160,000 to $276,000.
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)).
This position is eligible to participate in the Company's long-term incentive program.
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
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on April 21, 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
The anticipated base pay range for this position is :
$160,000-$276,000
Additional Description for Pay Transparency:
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)). This position is eligible to participate in the Company's long-term incentive program. 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. http://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.
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
People Leader
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 a Director, North America Regulatory Leader (Oncology) to be in Raritan, NJ; Titusville, NJ; or Spring House, PA.
Purpose:
The Director, North American Regulatory Leader, is responsible for the development, implementation and maintenance of North American regulatory strategies.
You will be responsible for:
The development, implementation and maintenance of robust North American/ regulatory strategies.
Leading the North America discussions during the Global Regulatory Team and be a key contributor on multiple cross-functional teams such as Compound Development Team (CDT).
Providing strategic direction to the teams and critical review of key Health Authority submissions such as IND/NDA/BLAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.
Ensuring that NA regulatory strategies are in alignment with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile
Interacting with the Health Authorities, the NARL will lead and/or participate in meetings with FDA, Health Canada, and other Health Authorities (HAs) if appropriate.
Developing a regulatory strategy that will deliver global and/or regional needs with initial focus on the key markets identified.
Ensuring business compliance, support due diligence activities, implement drug development strategies and adhere to regulatory standards.
Establishing North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs as well as addendums & supplements.
Serving as primary point of contact for US FDA
Ensuring US Business Partners are consulted and provided input into US regulatory strategies, PMR fulfillments, and other US-related issues.
Leading the regulatory response team for FDA and Health Canada questions.
Managing routine maintenance submissions, manage & track NA post-approval commitments, provide input and review submission documents, as well as approves submissions before dispatching to regulatory authorities
Contributing to the development of the USPI, lead the development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as well as reviews FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct.
Engaging in TA and department workstreams and initiatives to lead scientific innovation and process improvements/efficiencies.
Qualifications / Requirements:
Education:
Minimum of a Bachelor's degree in scientific or equivalent discipline is required
Advanced Degree (MS, PhD, PharmD) is preferred
Required:
Minimum of 10-12 years of relevant work experience
Experience leading interactions with Health Authorities
Broad understanding and experience in drug development, including early and late development, as well as a broad understanding of lifecycle management.
Ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment.
Working knowledge of US labelling requirements.
In depth knowledge of current US FDA, Health Canada and/or global regulations as they relate to overall regulatory strategy.
Experience managing a portfolio of multiple products.
Ability to work successfully in a matrixed environment as a leader and individual contributor.
People and project management skills, strong oral & written communication skills and organization & multi-tasking skills.
Preferred:
Previous experience in the oncology therapeutic area and/or advanced therapy modality
The anticipated base pay range for this position in the US is $160,000 to $276,000.
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)).
This position is eligible to participate in the Company's long-term incentive program.
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
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on April 21, 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
The anticipated base pay range for this position is :
$160,000-$276,000
Additional Description for Pay Transparency:
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)). This position is eligible to participate in the Company's long-term incentive program. 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. http://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.