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 Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

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 is recruiting for a Manager, RA Submissions. The position can be located in Springhouse, PA, Titusville, NJ or Raritan, NJ. The position will manage Clinical Trial Applications as a member of the Next Generation Submissions (NGS) organization.

Key Responsibilities:

• Be responsible for the operational management and delivery of global clinical trial regulatory submissions.
• Create and handle dossier plans/submission packages in line with clinical trial regulatory strategy,
• Support decision making impacting the quality and timeliness of Clinical Trial Health Authority submissions
• Make decisions on clinical trial submission operational strategies for the best project management approach within process/timeline/resource constraints.
• Lead Clinical Trial Submission Team meetings to coordinate the preparation and maintenance of regulatory submissions and filings.
• Take a leadership role for the monitoring and efficiency of the submission process and initiate changes within the scope of decision-making authority to minimize inefficiencies and ensure / improve quality.
• Cultivate effective relationships, maintaining open communication with key partners to ensure priority conflicts, resource issues, and deviations from the plan are identified and resolved.
• Develop departmental work practices, process enhancements / improvements, and associated training materials
• May be responsible for performance and development of direct reports.

Qualifications, Experience and Skills:

• University/bachelor’s degree and 6 years of related professional experience, or
• Masters/PharmD/PhD in combination with 4 years of relevant/related professional experience
• In-depth understanding of drug development process
• Ability to demonstrate in-depth knowledge of clinical trials regulatory submissions, filings, and processes
• Ability to work and lead in a matrix environment
• Proven ability to build positive relationships and influence stakeholders across an organization
• Proficiency in relevant clinical trials submission-related Health Authority and Industry regulations and guidelines
• Proficient use of Regulatory Information Systems
• Fluency in English; other languages may be required depending on assignment.
• Project / submission management proficiencies
• Previous experience leading Clinical Trial Submission Team meetings to coordinate the preparation and maintenance of submissions and filings

Other

• May lead and/or contribute to special projects and participate in process improvement initiatives.
• May require up to 5% travel, domestic and international.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• Titusville, NJ; Raritan, NJ; or Springhouse, PA - Requisition #: R-037131
• Switzerland - Requisition #: R-042460
• Belgium, Netherlands and Poland - Requisition #: R-042463
• UK- Requisition #: R-042464

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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.

Required Skills:

Preferred Skills:

Coaching, Compliance Management, Continuous Improvement, Design Thinking, Package and Labeling Regulations, Process Improvements, Product Packaging Design, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Standard Operating Procedure (SOP), Strategic Thinking, Sustainability, Sustainable Packaging, Technical Credibility, Transparency Reporting

The anticipated base pay range for this position is :

$100,000-$172,500

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.