Lead Regulatory Scientist, Immunology

Janssen Research & Development, LLC is recruiting for a Lead Regulatory Scientist based out of Spring House, PA. Remote work options in North America may be considered on a case-by-case basis and if approved by the Company.

At Janssen, we never stop working toward a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension. Visit us: www.janssen.com

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The Lead Regulatory Scientist provides support for regulatory activities for products in the assigned portfolio, including ensuring that content and intent of regulatory filings support the global regulatory strategy.

Key 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 have interaction with internal and external colleagues with coordination between departments
• May represent J&J or company externally with some degree of supervision
• Proactively anticipates issues; exercises judgment in developing new approaches/solutions and resolving issues
• Influences or persuades others within area of immediate responsibility, scope and level to accept new ideas, practices and approaches

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
• Skilled at effectively 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

Preferred:

• Understanding of regulatory submission and approval process and applicable US and EMA regulatory guidelines is preferred
• Relevant regulatory affairs experience in pharmaceutical/biotech is preferred
• Experience responding to Healthy Authority (HA) requests, managing HA interactions and life cycle management of IND/CTA/NDA/MAA applications is preferred
• Project management experience and ability to manage multiple priorities is preferred
• Diverse therapeutic area experience is preferred
• Direct experience in regulatory affairs is preferred
• Regulatory, Clinical or R&D experience with products in early and late development stages is preferred
• Experience responding to FDA requests, leading FDA interactions, and lifecycle management of IND/NDA applications is preferred
• Immunology Drug Development experience is preferred

Other:

• 10% domestic travel and potential international travel may be required for this position

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