At a Glance
- Tasks: Oversee regulatory submissions and ensure compliance with industry standards.
- Company: Dynamic pharmaceutical company focused on innovative drug development.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on quality and efficiency.
- Why this job: Join a team making a real impact in the pharmaceutical industry.
- Qualifications: Bachelor’s degree in Life Sciences and 5 years of relevant experience required.
The predicted salary is between 40000 - 50000 £ per year.
Job Overview
Collaborate with peers across the organization to achieve client-centric delivery in a matrix organization.
Collaboration across all stakeholders within Site Readiness.
Oversight and accountability of Regulatory Authority (RA), Independent Review Board (IRB)/Ethics Committee (EC) and Third Body submissions for designated projects within Site Readiness.
Please apply only if you are based in the listed countries.
Summary of Responsibilities
- Oversight and accountability for RA, IRB/EC, and Third Body submissions, including submission strategy, timeline planning, and delivering to the agreed upon timelines by tracking submission/approval timelines against projected milestones within relevant systems.
Coordinate responses to queries ensuring required timelines are met.
Provides consolidated country requirements and regular status updates to project team and Client, as applicable.
May be assigned to larger projects in terms of size and complexity in regional and/or global role.
- Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and client requests by preparing, reviewing, and providing input to core study documents as applicable.
This may include the compilation, review and distribution of core package, QC of core package, and country packages, maintenance and close out.
- Provide the highest quality advice on regulatory issues to members of project teams and its clients by maintaining awareness of current regulatory legislation, guidance and practice related to RA, IRB/EC, and Third Body submissions.
Evaluate the impact of clinical/regulatory changes on assigned projects as well as overall business operations.
- Liaise with and/or support local teams to liaise with RA, IRB/EC, and Third Bodies on behalf of clients.
- Where applicable and if suitably experienced, provide guidance and regulatory expertise on the application of the EU CTR in CTIS to other stakeholders.
Manage applicable user access to CTIS and act as a backup in case of unexpected absences of other team members.
- Ensure responsible deliverables are met within required timelines maintaining awareness of Green Light (GL) approval and Site Ready to Enroll (RTE) milestones.
Proactively identifying and escalating to Start-up Lead any risk to meeting deliverables.
- Manage projects according to the billing guide to ensure the work is performed within budget. Notify the Start-Up Lead of hours identified as Out-of-Scope or overburn.
- Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met.
Initiate improvements to enhance the efficiency and the quality of the submission work performed on assigned projects.
Support audits (internal and external) and inspections, as needed.
Support resolution of any findings
Qualifications (Minimum Required)
- Bachelor’s Degree in Life Sciences or equivalent, possibly with a higher qualification.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Understanding of and ability to determine relevance of governmental regulatory processes and regulations as they pertain to investigational drug regulations.
Experience (Minimum Required)
- Minimum of 5 years’ experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development.
- Excellent communication, organization, and planning skills with an attention to detail.
- Direct supervisory and project management skills and ability to work independently.
- Learn more about our
EEO & Accommodations request here .
Regulatory Submissions Manager - EMEA in Leeds employer: Fortrea
Fortrea is an exceptional employer that fosters a dynamic and collaborative work culture in Maidenhead, England. With a strong emphasis on employee growth and development, we offer comprehensive training programs and opportunities for advancement within the pharmaceutical sector. Our commitment to innovation and client success ensures that you will play a pivotal role in shaping the future of healthcare while enjoying a supportive environment that values your contributions.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Submissions Manager - EMEA in Leeds
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If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Fortrea. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Fortrea is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Submissions Manager - EMEA in Leeds
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Fortrea!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Fortrea that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Fortrea!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Fortrea, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Fortrea
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Fortrea that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Fortrea’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
