Senior Analyst, Regulatory Affairs

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

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Analyst, Regulatory Affairs. This is a hybrid position and will be located in Spring House, PA.

The Senior Analyst, Regulatory Affairs will provide support for regulatory activities for products in the assigned portfolio, including ensuring that content and intent of regulatory filings support the global regulatory strategy.

Principal 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 and lead team meetings as appropriate.
• Review clinical trial plans, protocols and submission plans ensuring alignment with regulatory requirements.
• Advise team in required documents and submission strategies.
• Support the development and improvement of processes related to regulatory submissions.
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints.
• Keep abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidances and requirements related to those areas.
• Interact with Health Authorities (HA) regarding program-specific issues and serve as secondary HA point-of-contact.
• May interact with internal and external colleagues with coordination between departments.
• May represent Johnson & Johnson or company externally with some degree of supervision.
• Proactively anticipates issues; exercises judgment in developing new approaches/solutions and resolving issues.
• Influence or persuade others within area of immediate responsibility, scope and level to accept new ideas, practices and approaches.

Qualifications:

• A minimum of a Bachelor's degree in a scientific or related discipline is required. Advanced degree (Master's, PharmD, Ph.D.) preferred.
• A minimum of 6 years of relevant experience with a Bachelor's degree; a minimum of 4 years of relevant experience with a Master's degree; or a minimum of 2 years of relevant experience with a PharmD/Ph.D. degree is required.
• Previous health regulatory industry experience is required.
• Understanding of the drug development or device process is required.
• Relevant regulatory affairs experience in pharmaceutical/biotech is preferred.
• Understanding of the regulatory submission and approval process and applicable U.S. and European Medicines Agency (EMA) regulatory guidelines is preferred.
• Experience responding to Healthy Authority (HA) requests, managing HA interactions and life cycle management of IND/CTA/NDA/MAA applications preferred.
• Experience responding to FDA requests, leading FDA interactions, and lifecycle management of IND/NDA applications is preferred.
• Regulatory, Clinical or R&D experience with products in early and late development stages is preferred.
• Diverse therapeutic area experience is preferred.
• Immunology drug development experience is preferred.
• Project management experience with the ability to manage multiple priorities is preferred.
• Demonstrated ability to effectively prioritize 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.
• Must have excellent communication and interpersonal skills.
• This position will require up to 10% travel.

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.

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