Sr RA Professional Submissions

Johnson & Johnson; High Wycombe; On-site; GBP 40,000 - 70,000; Full time

Job summary

A leading company in healthcare innovation seeks a Senior Regulatory Affairs Professional for Clinical Trial Applications in High Wycombe, UK. The role involves managing submissions to Health Authorities and enhancing dossier processes, with a focus on compliance and efficiency. Ideal candidates will possess strong interpersonal skills and a background in pharma, contributing to crucial clinical trials.

Qualifications

• 4-6 years in pharma or related field.
• Fluency in English; additional languages may be required.

Responsibilities

• Create/manage Dossier Plans and Submission Packages.
• Lead Clinical Trial Working Group Meetings.
• Monitor and enhance dossier processes.

Skills

Interpersonal skills

Teamwork

Communication skills

Understanding of product development processes

Education

University/Bachelor’s degree

Masters/Pharm D or PhD

Job description

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:

High Wycombe, Buckinghamshire, United Kingdom

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

Position:

We are searching for the best talent for Sr RA Professional Submissions for Clinical Trial Applications to be based in High Wycombe, UK.

From mid-2026, our offices in Wokingham and High Wycombe will move into a modern, new Johnson & Johnson office in central Maidenhead, next to the train station.

This role is available across multiple countries and may be posted under different requisition numbers to meet local requirements. You may apply to any or all postings, but we recommend focusing on the country(s) that match your preferred location(s):

Netherlands, Poland – Requisition Number: R-018738

All applications to multiple postings will be considered as a single submission.

Purpose:

As a Sr RA Professional Submissions for Clinical Trial Applications, you will collaborate to ensure compliant, timely submissions to Health Authorities during the clinical trial lifecycle. You will coordinate dossier plans, submission packages, and track submission and approval dates. You may also lead or contribute to special projects and process improvements.

Responsibilities:

• Dossier Management: Create/manage Dossier Plans and Submission Packages, ensuring compliance and complete documentation.
• Review and Tracking: Review dossiers and monitor document statuses with functional owners.
• Meeting Leadership: Lead Clinical Trial Working Group Meetings and resolve issues related to timelines and documentation.
• Process Improvement: Monitor and enhance dossier processes and participate in departmental projects.
• Document Support: Create/sign submission documents and support regulatory publishing.
• System Utilization: Use regulatory information management systems for dossier compilation and publishing.

Qualifications / Requirements:

• University/Bachelor’s degree or equivalent experience with 4-6 years in pharma or related field.
• A Masters/Pharm D or PhD is a plus.
• Fluency in English; additional languages may be required.
• Effective interpersonal, teamwork, and communication skills.
• Strong understanding of product development processes.