Senior Regulatory Affairs Scientist

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

14h•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Johnson & Johnson is responsible to our employees who work with us throughout the world, providing an inclusive work environment where each person is considered as an individual, respecting diversity and dignity, and recognizing merit. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries work on teams that save lives by developing the medicines of tomorrow, developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. 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.

Requirements

A minimum of a Master’s degree in a scientific or technical discipline is required.
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.
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 proactively anticipate issues and exercise judgment in developing new approaches/solutions to resolve 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.

Nice To Haves

Advanced degree (PharmD, Ph.D.) in a scientific or technical discipline preferred.
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.
Analytical Reasoning
Business Writing
Coaching
Compliance Risk
Fact-Based Decision Making
Industry Analysis
Legal Support
Process Improvements
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Risk Assessments
Strategic Thinking
Technical Credibility

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.

Benefits

annual performance bonus
medical insurance
dental insurance
vision insurance
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
long-term incentive program
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