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Johnson & Johnson Innovative Medicine · 4 hours ago

Director, Global Regulatory Leader

Titusville, NJ

Full-time

Hybrid

Director/Executive

$164K/yr - $283K/yr

10+ years exp

Johnson & Johnson Innovative Medicine is a leader in healthcare innovation, committed to developing smarter and less invasive treatments. The Director, Global Regulatory Leader will be responsible for developing and implementing global regulatory strategies for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area.

Pharmaceuticals

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

Qualification

Global regulatory experienceU.S. FDA expertiseRegulatory submission processImmunology therapeutic knowledgeAdvanced therapies knowledgeRegulatory complianceRegulatory developmentAnalytical reasoningBusiness writingTechnical credibilityStrategic thinking

Required

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

Preferred

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