Senior Manager, North America Regulatory Liaison

Johnson & Johnson

Senior Manager leading regulatory submission strategy and Health Authority interactions for Innovative Medicine at Johnson & Johnson. Collaborating with global teams and managing submissions through approvals.

Posted 5/8/2026full-timeTitusville • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $137,000 - $235,750 per yearWebsite

About the role

Key responsibilities & impact

Key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approvals.
In collaboration with the global regulatory team, develop global submission plans and Health Authority interaction plans.
Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
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.
Understand the regulatory framework, including regional trends, for various types of applications and procedures across all regions.
Collaborate with cross-functional submission delivery teams.
Participate and coordinate Health Authority interactions by leading regulatory team members and cross-functional team members.
Serve as primary point-of-contact to Health Authority.
If necessary, this position may work as Regional Regulatory Leader.
May represent Johnson & Johnson or company externally with limited supervision.
May cultivate and leverage strategic networks and partnerships.

Requirements

What you’ll need

A minimum of a Bachelor’s degree in a scientific or technical discipline is required.
Advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline preferred.
A minimum of 8 years of relevant Regulatory Affairs experience in pharmaceutical, biotech or consumer over the counter (OTC) industry is required.
A minimum of 8 years of relevant regulatory experience with a Bachelor’s degree; a minimum of 6 years of relevant regulatory experience with a Master’s or PharmD degree; or a minimum of 4 years of relevant regulatory experience with a Ph.D. is required.
Knowledge of clinical drug development is required.
Experience working with the U.S. FDA and global regulatory Health Authorities (HAs) is required.
Experience responding to FDA and other HA requests and managing HA interactions is required.
Experience in lifecycle management of IND/NDA/CTA/MAA and other regulatory submissions is required.
Demonstrated experience in critically reviewing and compiling regulatory documents is required.
Experience in the Neuroscience therapeutic area is preferred.
Experience in people management/coaching/mentoring is preferred.
Must have excellent communication and interpersonal skills.
Must have strong organization and time management skills.
Must have the ability to exercise independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel solutions.
Must have strong leadership capabilities with the ability to work successfully in a matrixed environment.
The ability to effectively prioritize assignments for multiple products and projects simultaneously is required.
The ability to collaborate with all levels and influence decision-making within a cross-functional organization is required.

Benefits

Comp & perks

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
retirement plan (pension)
savings plan (401(k))
annual performance bonus
vacation - 120 hours per calendar year
sick time - 40 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
Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave - 10 days
Volunteer Leave - 4 days
Military Spouse Time-Off - 80 hours

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submission strategyregulatory applicationssubmission delivery plansclinical protocolsregulatory expertiseIND/NDA/CTA/MAA submissionsregulatory document reviewclinical drug developmentlifecycle managementNeuroscience therapeutic area

Soft Skills

communication skillsinterpersonal skillsorganization skillstime management skillsindependent judgmentproblem-solvingleadership capabilitiescollaborationinfluencing decision-makingcoaching/mentoring

Certifications

Bachelor’s degreeMaster’s degreePharmDPh.D.