Director, Global Regulatory Leader

6084-Janssen Research & Development Legal Entity • Raritan, NJ

11h • Hybrid

About The Position

The Director, Global Regulatory Leader, is responsible for global regulatory strategies for select projects spanning the oncology therapeutic area. You will be responsible for: Responsible for the development, implementation, and maintenance of robust Global regulatory strategies. Applies expert analysis and interpretation of scientific data in assessing risk and in the creation of regulatory strategies to expedite new product introductions to the market. Lead the Global Regulatory Team and be a key contributor to multiple cross-functional teams such as Compound Development Team (CDT) to ensure timely commercialization of new and modified products into key markets. Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications. Ensure that regulatory strategies are aligned with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned). In interacting with the Health Authorities, the individual will lead and/or participate in meetings with Global Health Authorities (HAs) as appropriate. Ensure business compliance, support due diligence activities, implement drug development strategies, and adhere to regulatory standards. Achieves compliance with regulatory agency regulations by providing expert counsel to enable products that are developed, manufactured, or distributed to meet required legislation. Proactively creates a purpose driven environment by aligning Johnson & Johnsons Credo and Leadership Imperatives with the strategies and goals of the team and enterprise. Serve as a member of Labeling Working Group (LWG) to build or update the Company Core Data Sheet (CCDS) and for the target label contributes to the development of local labels as appropriate. Provides regulatory input to clinical development programs, risk/benefit assessments, and medical affairs programs. Provide integrated global labeling and filing strategies for assigned projects.

Requirements

• Minimum of a Bachelor’s degree in scientific discipline, Bachelor’s degree and 10+ years proven experience OR; Master’s degree/ PharmD and 7+ years of proven experience OR; PhD and 5+ years of proven experience.
• Experience leading interactions with Health Authorities is required.
• Global regulatory experience is required for the GRL role.
• Experience in drug development including early and/or late development, as well as a broad understanding of lifecycle management is required.
• Ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment is required.
• Ability to work successfully as a leader and individual contributor is required.

Nice To Haves

• Previous experience in the oncology therapeutic area is highly preferred.
• Understanding of US and EMA labelling requirements for GRL role is preferred.
• In depth knowledge of current US FDA, Health Canada (and EMA for GRL) and global regulations as they relate to overall regulatory strategy is preferred.

Responsibilities

• Responsible for the development, implementation, and maintenance of robust Global regulatory strategies.
• Applies expert analysis and interpretation of scientific data in assessing risk and in the creation of regulatory strategies to expedite new product introductions to the market.
• Lead the Global Regulatory Team and be a key contributor to multiple cross-functional teams such as Compound Development Team (CDT) to ensure timely commercialization of new and modified products into key markets.
• Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.
• Ensure that regulatory strategies are aligned with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned).
• In interacting with the Health Authorities, the individual will lead and/or participate in meetings with Global Health Authorities (HAs) as appropriate.
• Ensure business compliance, support due diligence activities, implement drug development strategies, and adhere to regulatory standards.
• Achieves compliance with regulatory agency regulations by providing expert counsel to enable products that are developed, manufactured, or distributed to meet required legislation.
• Proactively creates a purpose driven environment by aligning Johnson & Johnsons Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.
• Serve as a member of Labeling Working Group (LWG) to build or update the Company Core Data Sheet (CCDS) and for the target label contributes to the development of local labels as appropriate.
• Provides regulatory input to clinical development programs, risk/benefit assessments, and medical affairs programs.
• Provide integrated global labeling and filing strategies for assigned projects.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Director