Senior Regulatory Affairs Professional

Johnson & Johnson

Sr. Regulatory Affairs Professional at Johnson & Johnson supporting drug development and regulatory strategies.

Posted 5/14/2026full-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

Pharm D/PhD with 2-5 years’ experience OR Masters with 3-5 years of experience is required.
Understanding of the drug development process.
Previous experience in a health regulated industry preferred.
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.
Strong interpersonal and communication skills.

Benefits

Comp & perks

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 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
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

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory submission processregulatory approval processclinical trial plansprotocolssubmission plansdrug development processlife cycle management applicationsregulatory affairscompetitor intelligenceregulatory strategy

Soft Skills

interpersonal skillscommunication skillsproject managementproblem-solvinginfluencing skillsdecision makingteam leadershipcross-functional collaborationjudgmentproactive issue anticipation

Certifications

Pharm DPhDMasters