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, 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

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...