Senior Manager, RA Submissions
Johnson & Johnson
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 GroupJob Sub Function:
Regulatory Product Submissions and RegistrationJob Category:
People LeaderAll Job Posting Locations:
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of AmericaJob 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
We are seeking Senior Manager, RA Submissions to be located Raritan, NJ, Titusville, NJ or Spring House, PA.
Job requirements:
Strong leadership capabilities, with proven experience in managing direct reports, mentoring junior staff, and fostering a collaborative work environment.
Proven understanding regulatory requirements related to Clinical Trial Applications, including ICH-GCP, EMA, and other relevant guidelines.
Demonstrated experience leading and managing the preparation, review, and submission of CTAs to regulatory bodies.
Exceptional analytical skills to identify potential issues, analyze complex data, and develop effective solutions in a fast-paced regulatory environment.
Effective verbal and written communication skills, with the ability to liaise confidently with internal teams and external partners.
Bachelor’s Degree or higher in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
Strong organizational skills with the ability to manage multiple submissions and regulatory deadlines simultaneously.
Ability to work or lead in a matrix environment.
Key Responsibilities
Lead and oversee a CTA team in planning, preparing, and maintaining regulatory submissions and filings, ensuring accuracy and compliance throughout the process. Provide guidance and support for direct reports to facilitate smooth submission workflows.
Manage all HR-related processes for the team, including performance management, development, and fostering a positive work environment. Ensure team members are aligned with organizational goals and standards.
Drive the coaching and professional development of team members and colleagues, promoting continuous improvement, skill enhancement, and a high-performance culture.
Maintain and promote up-to-date expertise on global and regional regulations, ensuring all submissions meet current guidelines, standards, and best practices.
Provide leadership and oversight to the CTA team, ensuring the application of appropriate regulatory submission standards, processes, and policies to ensure compliance with regulatory agencies.
Analyze team workload, prioritize assignments, and oversee the tracking of submission activities using relevant systems and tools to ensure timely delivery.
Lead the development and alignment of submission operational strategies with overarching regulatory strategies, ensuring coherence and efficiency.
Drive continuous improvement by leading the development and enhancement of departmental work practices, processes, and workflows.
Actively participate in CTA leadership team meetings, contributing strategic insights and supporting decision-making processes.
Ensure open, timely, and effective communication channels with all stakeholders and team members to facilitate smooth project execution and meet deadlines.
Foster strong collaborations with key partners to proactively identify and resolve conflicts related to priorities, resource allocation, or deviations from plans, removing obstacles to ensure project success. Collaborate across GRA functions and relevant groups as needed for assigned projects.
Education and Experience Requirements:
Bachelor’s degree and 8-10 years of overall experience required
7+ years of relevant industry experience; Masters/Pharm D/PhD with 6+ years’ experience preferred
People or team management experience required
Global CTA regulations knowledge and experience required
Project leadership experience required
Prior senior leadership experience preferred
Can work a hybrid schedule that includes work from home flexibility as well as a regular in-office requirement at one of the locations listed in the next section
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-040598
Switzerland- Requisition #: R-042491
Belgium, Netherlands and Poland- Requisition #: R-042494
UK- Requisition #: R-042495
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:
Compliance Management, Cross-Functional Collaboration, Design Thinking, Developing Others, Inclusive Leadership, Leadership, Operational Excellence, Package and Labeling Regulations, Process Improvements, Product Packaging Design, Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Standard Operating Procedure (SOP), Strategic Thinking, Sustainability, Sustainable Packaging, Team Management, Transparency Reporting
The anticipated base pay range for this position is :
$120,000-$207,000Additional 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