Senior Regulatory Affairs Professional, Global TA

Johnson & Johnson

Sr. Regulatory Affairs Professional supporting drug development programs at Johnson & Johnson.

Posted 7/11/2026full-timeSpring House • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $109,000 - $174,800 per yearWebsite

About the role

Key responsibilities & impact

Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project-specific regulatory issues as assigned.
Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic area.
Assist in the preparation of meetings and act as backup for contact with Regulatory Agencies as needed
Ensure responses to Regulatory Agency queries are made in a timely manner, and that content is consistent with the regulatory strategy
Work cross-functionally, interact with internal and external colleagues with coordination between departments, and lead team meetings as appropriate
Advise team in required documents and submission strategies
Review clinical trial plans, protocols and submission plans ensuring alignment with regulatory requirements
Support the development and improvement of processes related to regulatory submissions
Provide regulatory input for and follow-up to inspections, audits, litigation support, and product complaints
Stay on top of current and pending approvals in assigned therapeutic areas and is knowledgeable of laws, guidelines and requirements related to those areas.
May interact with Health Authorities (HA) regarding program-specific issues and serve as secondary HA point-of-contact to represent J&J/Janssen externally with some degree of supervision

Requirements

What you’ll need

Bachelor’s degree in a scientific or equivalent discipline + 6 years experience in academia or industry OR Pharm D/PhD + 2 years experience OR Masters +3 years of experience is required.
Understanding of the drug development process.
Preferred: Previous experience in a health regulated industry
Understanding of regulatory submission and approval process and applicable US and EMA regulatory guidelines
Relevant regulatory affairs experience in pharmaceutical/biotech
Experience responding to HA requests, managing HA interactions, and life cycle management applications
Diverse therapeutic area experience
Experience within a cross-functional team environment as an individual contributor and decision maker
Proactively anticipates issues; exercises judgment in developing new approaches/solutions and resolving issues
Influences or persuades others within area of immediate responsibility, scope, and level to accept new ideas, practices and approaches
Skilled at project managing and effectively prioritizing assignments for multiple projects simultaneously

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)).
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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory RequirementsClinical Trial Protocol ReviewSubmission StrategiesCompetitor IntelligenceRegulatory Agency QueriesDrug Development ProcessRegulatory Guidelines KnowledgeLife Cycle ManagementTherapeutic Area ExpertiseProcess Improvement

Soft Skills

Judgment in Problem SolvingInfluencing OthersProactive Issue AnticipationEffective PrioritizationTeam Leadership