Associate Director, North American Regional Leader

Johnson & Johnson

Associate Director managing North American and global regulatory strategies for oncology projects at Johnson & Johnson. Focus on innovative treatment solutions and interventional oncology initiatives.

Posted 7/21/2026full-timeSpring House • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $137,000 - $235,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in regulatory submissions and interactions with US FDA and Health Canada, with a strong background in clinical drug development and lifecycle management of IND/NDA submissions. Proven ability to lead cross-functional teams and develop strategic regulatory input for key documents.

Highest-signal resume keywords

Regulatory Submission StrategyFDA Interaction ManagementIND/NDA Lifecycle ManagementRegulatory Document ReviewCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionClinical Drug DevelopmentRegulatory Document CompilationSubmission Delivery PlansLabeling Negotiation StrategiesHealth Authority InteractionSubmission Risk IdentificationPost-Approval CommitmentsUSPI DevelopmentRegulatory Expertise

Soft Skills

LeadershipCommunicationCollaborationStrategic ThinkingProblem Solving

Industry Keywords

BLANDAINDCTAHealth AuthoritiesFDAHealth CanadaClinical ProtocolsNonclinical ReportsCCDS

About the role

Key responsibilities & impact

Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs & supplements.
Serve as primary point of contact for US FDA.
Lead the regulatory response team for FDA and Health Canada questions.
Key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approvals.
Manage routine maintenance submissions, coordinate NA post-approval commitments, provide input and review submission documents, as well as approves submissions before dispatching to regulatory authorities.
Contributes to the development of the USPI, lead the development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as well as reviews FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct.
Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).
Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents.
Collaborate with cross-functional submission delivery teams.
Participate and coordinate Health Authority interactions by leading regulatory team members and cross-functional team members.
Ability to flex across different product types (pharma, devices, combo products)

Requirements

What you’ll need

Minimum of a Bachelor’s degree in scientific or equivalent discipline
Bachelor’s degree plus 8+ years relevant experience OR; Master’s degree/ PharmD plus 6+ years relevant experience, OR; PhD plus 4+ years relevant experience
Relevant regulatory experience and understanding of clinical drug development, working with US FDA and global regulatory health authorities
Experience responding to FDA and other Health Authorities (HA) requests and managing Health Authorities interactions
Experience in lifecycle management of IND/NDA and other regulatory submissions
Demonstrated experience in critically reviewing and compiling regulatory documents is required

Benefits

Comp & perks

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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 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
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year