Director, Global Regulatory Leader

Johnson & Johnson Innovative Medicine•Ambler, PA

2d•Hybrid

About The Position

The Director, Global Regulatory Leader in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of global regulatory strategies for investigational rare disease and advanced cell therapy products supporting programs in the Immunology Therapeutic Area. This position is a hybrid role and can be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company and will be available in all states within the United States. The Director, Global Regulatory Leader in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of global regulatory strategies for investigational rare disease and advanced cell therapy products supporting programs in the Immunology Therapeutic Area.

Requirements

A minimum of a Bachelor’s degree is required, preferably in a scientific or technical discipline.
A minimum of 10 years of global health regulated industry is required.
Global regulatory experience with deep expertise in U.S. FDA, EMA, and international regulations within scientific and commercial contexts is required.
Knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required.
An understanding of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.
An understanding of the regulatory submission and approval process is required.
Experience critically reviewing and compiling regulatory documents is required.
Demonstrated ability to interpret and apply regulatory requirements and precedents is required.
A proven track record in shaping global regulatory strategies, ensuring compliance, and leading direct interactions with Health Authorities is required.
Must have excellent oral and written communication skills.
Must have strong organization and multi-tasking skills.
The ability to exercise independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel and practical solutions is required.

Nice To Haves

Advanced degree (Master’s, PharmD or PhD) preferred.
Knowledge of the Immunology and Oncology therapeutic areas is strongly preferred.
Knowledge of advanced therapies, such as CAR-T, is strongly preferred.
A proven track record of working successfully within a collaborative team environment and building positive relationships as an individual contributor is preferred.
The ability to effectively prioritize assignments for multiple products and projects simultaneously is preferred.

Responsibilities

As the global regulatory lead for assigned projects, develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area.
Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market access plans.
Serve as the key regulatory point of contact, providing leadership and guidance across cross-functional teams to support successful development and commercialization, including providing input on implications of regulatory strategy through participation in product-related teams.
Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed.
Lead and/or participate in meetings with regulatory agencies as appropriate and prepare company personnel for interactions with Health Authorities (HAs).
Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.
Lead and oversee key health authority documents (e.g., IND/CTA, meeting requests, briefing packages, responses, marketing applications) according to the strategic plan for the region and health authority commitments.
Perform critical review of submission documents to ensure compliance with regulatory requirements.
Negotiate and manage regional post-approval commitments and global label expansion strategies.
Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues) and provide proactive strategic regulatory advice to project teams and global regulatory teams.
Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge and provide strategic regulatory input into clinical trial designs, labeling, risk management, and development programs to meet global and regional requirements.
Support due diligence and business development assessments.
Identify and resolve regulatory issues that may affect projects or organizational objectives.

Benefits

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
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
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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year