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- Tasks: Manage submissions for clinical trials and ensure compliance with health authorities.
- Company: Join Johnson & Johnson, a leader in healthcare innovation dedicated to improving lives.
- Benefits: Enjoy a modern office environment, flexible work options, and opportunities for professional growth.
- Why this job: Be part of a team that saves lives and pioneers groundbreaking treatments.
- Qualifications: Bachelor's degree with 4-6 years in the pharmaceutical industry; advanced degrees are a plus.
- Other info: Position available across multiple countries; apply based on your preferred location.
The predicted salary is between 48000 - 72000 £ per year.
Join to apply for the Sr RA Professional Submissions role at Johnson & Johnson Innovative Medicine
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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
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Sr RA Professional Submissions employer: Johnson & Johnson Innovative Medicine
Contact Detail:
Johnson & Johnson Innovative Medicine Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr RA Professional Submissions
✨Tip Number 1
Familiarise yourself with the regulatory landscape in the pharmaceutical industry, especially regarding clinical trial submissions. Understanding the specific requirements of Health Authorities can give you an edge during interviews.
✨Tip Number 2
Network with professionals already working in Regulatory Affairs or similar roles. Engaging with them on platforms like LinkedIn can provide insights into the company culture and expectations for the Sr RA Professional Submissions role.
✨Tip Number 3
Prepare to discuss your experience with dossier management and submission processes in detail. Be ready to share specific examples of how you've contributed to successful submissions in previous roles.
✨Tip Number 4
Stay updated on the latest trends and advancements in Innovative Medicine. Showing your passion for the field and understanding of current challenges can set you apart from other candidates during the interview process.
We think you need these skills to ace Sr RA Professional Submissions
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of the Sr RA Professional Submissions role. Familiarise yourself with the key tasks such as dossier management and regulatory compliance to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in regulatory affairs, particularly in clinical trial submissions. Mention specific projects or achievements that demonstrate your ability to manage dossiers and collaborate effectively with teams.
Craft a Compelling Cover Letter: Your cover letter should not only express your enthusiasm for the position but also outline how your skills align with Johnson & Johnson's mission in Innovative Medicine. Use specific examples to illustrate your qualifications and passion for healthcare innovation.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or typos. A polished application reflects your attention to detail, which is crucial in regulatory affairs. Consider asking a friend or colleague to review it as well.
How to prepare for a job interview at Johnson & Johnson Innovative Medicine
✨Understand the Role
Make sure you thoroughly understand the responsibilities of a Sr RA Professional Submissions. Familiarise yourself with dossier management, submission packages, and the regulatory landscape to demonstrate your knowledge during the interview.
✨Showcase Your Experience
Prepare to discuss your previous experience in regulatory affairs, particularly in clinical trial applications. Highlight specific projects where you successfully managed submissions or improved processes, as this will show your capability for the role.
✨Demonstrate Teamwork Skills
Since collaboration is key in this role, be ready to provide examples of how you've worked effectively in teams. Discuss any leadership roles you've taken in meetings or projects, especially those related to clinical trials.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to innovative medicine and regulatory challenges. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
