We Hire America Jobs

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