Senior Regulatory Affairs Scientist Full-time

Senior Regulatory Affairs Scientist

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Regulatory Affairs Scientist. This position is a hybrid role and can be located in Titusville, NJ; Raritan, NJ; or Spring House, PA.

Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter who is passionate about advancing their career in healthcare. GRA is a key strategic partner supporting global R&D initiatives at Johnson & Johnson Innovative Medicine. As a Senior Regulatory Affairs Scientist, you will support drug development programs as well as marketed products across multiple therapeutic areas. You will gain broad and diverse regulatory experience supporting compounds in early-to-late drug development as well as life-cycle activities for approved products in our portfolio via a flexible rotational model geared towards addressing business needs and individual career-development goals.

Through hands-on, real-world experiences, you will work on projects that improve your leadership, problem-solving, and creative thinking skills. Furthermore, you will acquire the business savvy to be successful in a complex, fast-paced, and innovative regulatory environment.

Principal Responsibilities:

• 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 be 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 Johnson & Johnson/Innovative Medicine externally with some degree of supervision.

Qualifications:

• A minimum of a Master's degree in a scientific or technical discipline is required. Advanced degree (PharmD, Ph.D.) in a scientific or technical discipline preferred.
• A minimum of 3 years of relevant Regulatory Affairs experience in pharmaceutical, biotech or consumer over the counter (OTC) industry with a Master's degree OR a minimum of 2 years of relevant Regulatory Affairs experience in pharmaceutical, biotech or consumer over the counter (OTC) industry is required.
• Understanding of the drug development process is required.
• Previous experience in a health regulated industry is required.
• Understanding of regulatory submission and approval process and applicable FDA and EMA regulatory guidelines is required.
• Experience responding to Health Authority (HA) requests, managing HA interactions, and life cycle management applications is preferred.
• Experience in the Neuroscience therapeutic area is preferred.
• Experience working within a cross-functional team environment as an individual contributor and decision maker is preferred.
• Experience project managing and effectively prioritizing assignments for multiple projects simultaneously is preferred.
• Must have excellent communication and interpersonal skills.
• Must have strong organization and multi-tasking skills.
• Must have the ability to proactively anticipate issues, exercising judgment in developing new approaches/solutions and resolving conflicts/issues.
• Must have the ability to influence or persuade others within area of immediate responsibility, scope, and level to accept new ideas, practices and approaches.
• The ability to collaborate with all levels and influence decision-making within a cross-functional organization is required.
• This position may require up to 10% travel.

The anticipated base pay range for this position in U.S. locations is $109,000 to $174,800.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• 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 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
• For additional general information on Company benefits, please go to: – https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on May 5, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.