DescriptionJohnson & Johnson is recruiting for a Senior Director, Global Regulatory, Immunology for its Pharmaceutical R&D business. Preferably, this role will be located in Spring House, PA, Zug, Switzerland, High Wycombe, UK, Beerse, Belgium. Remote work can also be considered on an individual basis.The Senior Director, Global Regulatory Leader, Immunology will be responsible for the development, implementation and maintenance of Global regulatory strategies for both large and small molecules with indications targeted in areas of primarily Rheumatology, Gastroenterology, Dermatology and Maternal/Fetal medicine. As a global regulatory leader, this individual will be responsible for leading complex Global regulatory teams and overseeing the activities of global regulatory professionals within this team and may be asked to serve as a direct line manager.Responsibilities:Lead multiple cross-functional teams including but not limited to the Global Dossier Team, Clinical Working Group, the Labeling Working Group, and the Compound Development Team. This will include serving as a member of LWG to create or update the CCDS and contribute to the development of local labels as appropriate and providing regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label.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. Provide integrated global labeling and global dossier submission strategy for assigned projects, working closely with NARLs, EURLs, and other regional leads in ensuring all local content requirements are met and HA questions are addressed.In interacting with the Health Authorities, the GRL will lead strategy and participate in meetings with FDA, EMA, and other Health Authorities (HAs) as appropriate. Includes preparing company personnel and developing contingency strategies for interactions with HAs. This role may serve as the GRA representative to Disease Area Strategy teams. At the manager's request, this role may also serve as a delegate to the TA Head on key TA governance committees such as PRC, IOC, and IPC on an ad hoc or permanent basis.The base compensation range for this role in the United States is $160,000-$257,000.QualificationsEducation:Bachelor's Degree Required. Advanced degree strongly preferred. MS, PhD, MD or Pharm D.Required Skills:10+ years of pharmaceutical industry/health authority experience is required; a minimum of 6 years of RA or related experience is requiredExperience leading interactions with Health Authorities is required.A broad understanding and experience in drug development including early and late development is required. A broad understanding of lifecycle management is required. The ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment is required. Working knowledge of US and EU labeling requirements is required. Knowledge of Global Health Authority structures & how Agencies operate; knowledge & understanding of commercial business needs; and understanding of scientific data (clinical & non-clinical) is required. Ability to work successfully in a matrixed environment as a leader (matrixed and or direct people manager) and individual contributor Project management skills, strong oral & written communication skills and organization & multi-tasking skills are requiredDisclaimer: This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job; it is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards. The incumbent shall perform all other functions and/or be cross-trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.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 are eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.Job Field: Regulatory AffairsOrganization: Janssen Research & Development, LLC (6084)Travel: Yes, 25 % of the Time