Join to apply for the Sr RA Professional Submissions role at Johnson & Johnson Innovative Medicine
1 week ago Be among the first 25 applicants
Join to apply for the Sr RA Professional Submissions role at Johnson & Johnson Innovative Medicine
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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
We are searching for the best talent for Sr RA Professional Submissions for Clinical Trial Applications to be in, High Wycombe, UK.
We are pleased to announce that from mid-2026, our offices in Wokingham and High Wycombe will move into a modern, brand new Johnson & Johnson office in central Maidenhead, conveniently situated next to the train station.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to align 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):
Netherlands, Poland – Requisition Number: R-018738
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Purpose
As a Sr RA Professional Submissions for Clinical Trial Applications, you will collaborate with colleagues to ensure compliant and timely submissions to Health Authorities worldwide through the entire lifecycle of the clinical trial. You will coordinate and compile dossier plans and submission packages as well as ensure tracking and communication of submission and approval dates. Additionally, you may lead and/or contribute to special projects and participate in process improvement initiatives.
You Will Be Responsible For
* Dossier Management: Create and manage Dossier Plans and Submission Packages, ensuring compliance with regulatory strategies and necessary document inclusion.
* Review and Tracking: Conduct dossier reviews and track document statuses in collaboration with functional area owners.
* Meeting Leadership: Lead Clinical Trial Working Group Meetings and help resolve issues related to timelines and document preparedness.
* Process Improvement: Monitor the effectiveness of the dossier process and participate in special projects to enhance departmental work practices.
* Document Creation/Support: Create and sign submission documents, providing component-level publishing support for regulatory deliverables.
* System Utilization: Apply regulatory information management systems for compiling and publishing dossiers according to submission requirements.
Qualifications / Requirements
* University/Bachelor’s degree or equivalent experience with 4-6 years in the pharmaceutical industry or related field.
* A Masters/Pharm D or PhD is a plus
* Fluency in English; other languages may be required depending on assignment.
* Effective interpersonal, teamwork, and communication skills.
* Strong understanding of the product development process.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Information Technology
* Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Johnson & Johnson Innovative Medicine by 2x
Sign in to set job alerts for “Senior” roles.
Senior PR & Marketing Manager – Northern Europe
Slough, England, United Kingdom 3 weeks ago
High Wycombe, England, United Kingdom 1 week ago
Beaconsfield, England, United Kingdom 1 day ago
Senior Director of NPD Programme Management
Uxbridge, England, United Kingdom 4 days ago
Senior Director, Global Product R&D – EMEA
Uxbridge, England, United Kingdom 1 week ago
Culham, England, United Kingdom 1 month ago
Beaconsfield, England, United Kingdom 1 week ago
Oxford, England, United Kingdom 2 weeks ago
Egham, England, United Kingdom 3 weeks ago
Frimley, England, United Kingdom 19 hours ago
Woking, England, United Kingdom 2 days ago
London, England, United Kingdom 9 months ago
Hammersmith, England, United Kingdom £80,000.00-£100,000.00 3 weeks ago
Uxbridge, England, United Kingdom 2 days ago
Richmond Upon Thames, England, United Kingdom 2 weeks ago
Uxbridge, England, United Kingdom 4 days ago
Oxford, England, United Kingdom 1 week ago
Slough, England, United Kingdom 3 weeks ago
Hounslow, England, United Kingdom 1 week ago
Maidenhead, England, United Kingdom 1 month ago
Lecturer or Senior Lecturer in Accounting
Addlestone, England, United Kingdom 2 weeks ago
Slough, England, United Kingdom £65,000.00-£72,000.00 2 weeks ago
Reading, England, United Kingdom 1 week ago
Uxbridge, England, United Kingdom 2 weeks ago
Luton, England, United Kingdom 2 days ago
Culham, England, United Kingdom 3 weeks ago
Feltham, England, United Kingdom 1 week ago
Isleworth, England, United Kingdom 10 hours ago
High Wycombe, England, United Kingdom 3 days ago
Reading, England, United Kingdom 4 weeks ago
Aylesbury, England, United Kingdom 23 hours ago
Culham, England, United Kingdom 3 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr