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Director – North America Regulatory Affairs
Johnson & JohnsonCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in developing and executing North American regulatory strategies, leading cross-functional teams, and managing regulatory submissions to ensure compliance with FDA and Health Canada requirements. Possesses strong leadership, communication, and project management skills to drive regulatory initiatives and influence stakeholders effectively.
Highest-signal resume keywords
North American Regulatory Strategy DevelopmentFDA Interaction ManagementRegulatory Submission OversightDrug Development Lifecycle ManagementPeople and Project Management Skills
About the role
Key responsibilities & impact- Develop, implement, and maintain North American regulatory strategies
- Develop and execute global and North American regulatory strategies
- Lead the North American Regulatory Team and provide strategic direction across cross-functional development teams
- Ensure North American alignment across portfolio priorities
- Oversee and critically review key regulatory submissions
- Lead and support interactions with the FDA
- Establish North American content requirements and timing for global dossier plans, including BLA/NDAs, IND/CTAs, addendums, and supplements
- Serve as the primary point of contact for the US FDA
- Lead regulatory response teams for FDA and Health Canada questions
- Consult with US Business Partners on US regulatory strategies, PMR fulfillments, and other US-related issues
- Manage routine maintenance submissions and track North American post-approval commitments
- Provide input on and review submission documents and approve submissions before dispatch to regulatory authorities
- Contribute to USPI development and lead North American labeling negotiation strategies
- Develop supporting labeling documentation and review FDA and Health Canada labeling for consistency with the CCDS
- Direct managers and senior individual contributors in a matrix environment
- Conduct career development conversations and provide coaching and feedback
- Establish functional Regulatory Affairs initiatives aligned with corporate strategies and compliance regulations
- Collaborate with R&D, Marketing, and other leaders on cross-functional policies and portfolio planning
- Recommend product development strategy solutions based on anticipated regulatory changes and emerging issues
- Partner with stakeholders to influence regulatory policies and positions
- Communicate regulatory policies and environmental changes to management
- Manage team operational matters, including budget, performance, compliance, workforce planning, and succession planning
- Create a purpose-driven environment aligned with Johnson & Johnson’s Credo and Leadership Imperatives
Requirements
What you’ll need- Minimum of a Bachelor’s degree in scientific or equivalent discipline is required
- Minimum of 10 years of relevant experience
- Experience leading interactions with Health Authorities
- US regulatory experience
- Broad understanding and experience in drug development, including early and late development and lifecycle management
- Ability to interpret and understand regulatory requirements and precedent in scientific and commercial contexts
- Working knowledge of US and EMA labeling requirements
- In-depth knowledge of current US FDA, Health Canada, EMA for GRL, and global regulations related to regulatory strategy
- Experience managing a portfolio of multiple products
- Ability to work successfully in a matrixed environment as a leader and individual contributor
- People and project management skills
- Strong oral and written communication skills
- Organization and multitasking skills
- Ability to exercise independent judgment and resolve complex organizational issues with novel solutions
- Ability to incorporate input from a broad range of stakeholders
- Ability to enhance business and work processes to support innovation
- Previous experience in oncology, cell therapies, or other complex modalities is preferred
Benefits
Comp & perks- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees
- 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 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Strategy DevelopmentRegulatory Submission ReviewDrug Development KnowledgeUS Regulatory ExperienceLabeling Requirements KnowledgePortfolio ManagementRegulatory ComplianceMatrix Environment LeadershipIndependent JudgmentComplex Problem Solving
Soft Skills
Strong Oral CommunicationStrong Written CommunicationOrganization SkillsMultitasking SkillsCoaching and Feedback
Industry Keywords
FDAHealth CanadaEMABLA/NDAsIND/CTAsOncologyCell TherapiesRegulatory AffairsPortfolio PrioritiesCross-Functional Collaboration