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We are searching for the best talent for Manager, Regulatory Affairs North America. This is a hybrid position (3 days in office and 2 days remote) and will be located in Spring House, PA.

Purpose: The Manager, Regulatory Affairs North America, acts as a 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

You will be responsible for:

• Conduct regulatory research to gather pertinent histories, precedents, and other information crucial for product advancement in the US.

• Record and convey details and outcomes of FDA interactions to the GRT and applicable senior management.

• Ensure regulatory compliance for products, including DSURs, Post-Market Commitments (PMCs), pediatric requirements, and other agency obligations.

• Under supervision, 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 and developing regulatory risks and mitigation scenarios

• 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, regulatory guidance on US regulatory mechanisms to optimize product development (e.g. orphan drug, fast track, early access, pediatric plan) 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 / Requirements:

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/PharmD with a minimum of 4 years of relevant experience

• A PhD with a minimum 2 years of relevant experience

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

• Previous health regulatory industry experience and understanding of the drug or device development process is required

• Relevant regulatory affairs experience in pharmaceutical/biotech is required

Preferred:

• Understanding of regulatory submission and approval process (eg, IND/CTA, and/or NDA/MAA fillings) and applicable US regulatory guidelines is strongly preferred. Experience responding to Healthy Authority (HA) requests, managing HA interactions and management of applications is strongly preferred.

• Project management experience is preferred

• Diverse therapeutic area experience is preferred

• Immunology Drug Development experience is preferred

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.