Senior Manager, RA Submissions

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:

People Leader

All Job Posting Locations:

Raritan, New Jersey, 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

We are seeking 3 Senior Managers, RA Submissions to be located in: USA (Raritan, NJ or Titusville, NJ) or EMEA (Turnhoustseweg, Belgium; Allschwil, Switzerland; High Wycombe, Great Britian; Leiden, Netherlands)

Purpose:

The Senior Manager, RA Submissions is a member of the CTA Leadership team and provides direct supervision to the CTA team responsible for the delivery of compliant regulatory submissions required to support the development and registration of products. This position supervises CTA staff at global locations and at multiple levels and drives achievement of team results. This position may be responsible for performing additional project or submission related work based on area of responsibility. The Senior Manager, RA Submissions makes decisions that impact CTA submissions that will be viewed by external authorities. This position makes decisions on strategies within process/timeline constraints and appropriate deviations from normal practice to meet unique challenges in the most efficient manner. The Senior Manager contributes to decisions on department guidelines, standards, processes, and resourcing. This position is charged with making decisions associated with the management of assigned personnel and local administration, including hiring and performance management. The Senior Manager, RA Submissions focuses on both short- and medium-term (1-2 years) needs of the department and their deliverables. This position may provide guidance to cross-functional teams about submissions strategy, processes, and timing. This position requires the ability to make decisions and resolve issues with limited supervision. The Senior Manager makes decisions for project and non-project staff assignments and resourcing. This position exercises independent judgment, and execution in anticipating, interpreting, evaluating and resolving complex organizational issues. This position keeps the supervisor apprised and solicits management support as needed.

The Senior Manager, RA Submissions must have knowledge of:

• 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.

You will be responsible for:

• 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 submiss