Global Regulatory Leader, Immunology & Cell Therapies

• 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

Requirements A minimum of a Bachelor’s degree is required, preferably in a scientific or technical discipline Advanced degree (Master’s, PharmD or PhD) preferred 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 Knowledge of the Immunology and Oncology therapeutic areas is strongly preferred Knowledge of advanced therapies, such as CAR-T, is strongly preferred 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 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 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 ATS Optimization Keywords Below are skills and terms extracted directly from this job posting to improve Applicant Tracking System (ATS) visibility. This unique feature helps candidates tailor their applications more effectively — a feature exclusive to JobTailor job listings. Hard Skills regulatory strategy development regulatory compliance submission document review clinical trial design labeling risk management advanced therapies drug product lifecycle global regulatory experience FDA and ICH guidelines Soft Skills leadership communication skills organizational skills multi-tasking collaboration relationship building independent judgment problem-solving strategic thinking prioritization Certifications & Qualifications Bachelor’s degree Master’s degree PharmD PhD #J-18808-Ljbffr Jobtailor