Senior Analyst, Regulatory Affairs, North America

Johnson & Johnson is recruiting for a Senior Analyst, 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 Senior Analyst, Regulatory Affairs, North America is an experienced and individual contributor who leads the establishment and implementation of planning and coordinating regulatory activities for assigned products in alignment with the global regulatory strategy.

Key Responsibilities:

• Participates in global and regional regulatory team meetings and advises the regulatory team on applicable regulatory requirements and project-specific regulatory issues as assigned
• Maintains an understanding of the US regional regulatory environment and competitive intelligence within assigned programs
• Assists in the preparation of Health Authority interactions and act as backup for contact with Regulatory Agencies as needed
• Supports/leads coordination of responses to Regulatory Agency queries in collaboration with the cross-functional team in a timely manner, consistent with the regulatory strategy
• Reviews clinical trial plans, protocols and submission plans, ensuring alignment with regulatory requirements
• Coaches product development teams on input for product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process
• Assists in managing, preparing and submitting detailed regulatory submissions required for new and existing product approvals and registrations
• Establishes regulatory affairs interpretation and feedback to support internal and external audits
• Coaches more junior colleagues in techniques, processes and responsibilities
• Proactively anticipate issues; exercise judgment in developing new approaches and solutions
• Understands and applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with team

Qualifications

Education:

One of the following combinations of education and experience is required:

• A Bachelor's Degree with a minimum of 6 years of relevant experience
• An Advanced/Master's Degree with a minimum of 4 years of relevant experience
• A PharmD/PhD with a minimum 2 years of relevant experience

Experience and Skills:

Required:

• Previous health regulatory industry experience and understanding of the drug development process is required
• Relevant regulatory affairs experience in pharmaceutical/biotech is required
• Understanding of regulatory submission and approval process and applicable US regulatory guidelines is required
• Experience responding to Healthy Authority requests and managing the IND/BLA/NDA lifecycle is required
• Skilled at effectively prioritizing assignments for multiple projects simultaneously is required
• Experience within a cross-functional team environment as an individual contributor 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