Job Information
J&J Family of Companies Manager, Regulatory Affairs North America in Spring House, Pennsylvania
Manager, Regulatory Affairs North America - 2406185951W
Description
Johnson & Johnson is recruiting for Manager, Regulatory Affairs North America. The position can be located in Spring House, PA.
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. Learn more at https://www.jnj.com/
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Manager, Regulatory Affairs North America, Acts as a top-level specialist on the global regulatory sub team and cross-functional project teams in the development of regulatory strategy and submission plans to ensure timely commercialization of new and modified products into North American markets.
Key Responsibilities:
Interact with Health Authorities (HA) regarding program-specific issues and serve as secondary HA point-of-contact
Assist in the preparation of HA interactions and coordinate team readiness for interactions, including strategic planning
Support/lead coordination of responses to Regulatory Agency queries in collaboration with the cross-functional team, consistent with the regulatory strategy
Consult on compliance with regulations by providing in depth knowledge to enable products that are developed, manufactured, or distributed to meet required regulatory agency regulations
Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project-specific regulatory issues and submission strategies
Maintain an in-depth understanding of the regional regulatory environment and competitive intelligence within assigned programs and therapeutic portfolio
Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints
Review clinical trial plans, protocols and submission plans, ensuring alignment with regulatory requirements
Provide guidance for teams on product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process
Influence others within area of immediate responsibility, scope and level to accept new insights, practices and approaches
Proactively anticipate issues; exercise judgment in developing new approaches/solutions and resolving issues
Coaches and trains junior colleagues in techniques, processes, and responsibilities
Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.
Qualifications
Education:
One of the following combinations of education and experience is required:
A Bachelor’s Degree with a minimum of 8 years of relevant experience
An Advanced/Master’s Degree with a minimum of 6 years of relevant experience
A PharmD/PhD with a minimum 4 years of relevant experience
Required:
Previous health regulatory industry experience and understanding of the drug development process is required
Direct experience in regulatory affairs is required
Understanding of regulatory submission and approval process and applicable US regulatory guidelines is required
Relevant regulatory affairs experience in pharmaceutical/biotech is required
Experience responding to Healthy Authority (HA) requests, managing HA interactions and management of applications is required
Skilled at optimally prioritizing assignments for multiple projects simultaneously is required
Experience within a cross-functional team environment as an individual contributor and decision maker within a matrix organization is required
Strong interpersonal and communication skills is required
10% domestic travel and potential international travel may be required for this position
Preferred:
Project management experience is preferred
Diverse therapeutic area experience is preferred
Immunology Drug Development experience is preferred
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com
This job posting is anticipated to close on 7/9/24. 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.
Primary Location NA-US-Pennsylvania-Spring House
Organization Janssen Research & Development, LLC (6084)
Job Function Regulatory Affairs
Req ID: 2406185951W
J&J Family of Companies
- J&J Family of Companies Jobs