Associate Local Trial Manager

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

Copenhagen

Job Description:

About Innovative Medicine

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 looking for an experienced EU Clinical Trial Regulatory Specialist with strong hands-on experience in EU CTR submissions. The role requires solid regulatory knowledge, attention to detail, and the ability to work efficiently in a fast‑paced, deadline‑driven environment.

Key Responsibilities

• Prepare, coordinate, and submit EU CTR applications (initial submissions, substantial modifications, notifications, and ASRs)

• Ensure regulatory submissions are complete, accurate, and compliant with EU CTR and local requirements

• Coordinate with internal stakeholders (Clinical Operations, Regulatory Affairs, Start‑Up teams) and external parties

• Support responses to RFIs (Requests for Information) from Competent Authorities and Ethics Committees

• Maintain high quality and compliance of regulatory documentation

• Track submission timelines and manage multiple submissions in parallel

Required Experience

• Proven experience with EU CTR submissions under Regulation (EU) No 536/2014

Experience with:

• Initial CTA submissions

• Substantial Modifications (Part I and/or Part II)

• Notifications and lifecycle management

• Experience in a pharmaceutical company, CRO, or clinical research environment

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Behavior, Business English, Clinical Data Management, Clinical Trials, Clinical Trials Operations, Execution Focus, Issue Escalation, Laboratory Operations, Process Improvements, Process Oriented, Project Support, Regulatory Environment, Research and Development, Research Ethics, Study Management, Time Management