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- Tasks: Lead regulatory submissions and ensure compliance with protocols in clinical operations.
- Company: Join Parexel, a leader in clinical studies with a supportive culture.
- Benefits: Enjoy job security, career development, and a friendly work environment.
- Why this job: Make a real impact on life-changing clinical trials and drug developments.
- Qualifications: Extensive experience in regulatory submissions and local compliance knowledge required.
- Other info: Opportunities for growth and skill development across various departments.
The predicted salary is between 60000 - 75000 £ per year.
Parexel FSP is currently registering interest for experienced Regulatory & Submissions Leads to join our team in the UK, dedicated to a large single sponsor. This will be a home‑based position.
Working at Parexel offers tremendous long‑term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top‑50. We have an incredible pipeline of work and a world of opportunity waiting for you.
The Regulatory & Submissions Lead is accountable for performance and compliance with assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
Experience Required To Be a Fit For This Role
- Extensive experience in local EC and RA submission (must be familiar with XML completion) – including initial submission and protocol amendments submission.
- Experience in independently preparing submissions (CTC supports with documents collection) to both EC and RA.
- Experience in ICF preparation using templates.
- Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start‑ups.
- Experience in IMP supplies management at the local level (vendors providing background meds, the standard of care, etc.).
- Experience in validation of translated documents.
We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long‑term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today’s top 50 best‑selling drugs, but equally we enable more niche drug developments that are critical to the well‑being of many patients. You’ll be an influential member of the wider team.
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Regulatory & Submissions Lead (Clinical Operations Manger) - London, UK, Hybrid - FSP - REGISTE[...] in Uxbridge employer: Parexel
Contact Detail:
Parexel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory & Submissions Lead (Clinical Operations Manger) - London, UK, Hybrid - FSP - REGISTE[...] in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about letting people know you’re on the lookout for opportunities. You never know who might have the inside scoop on a role that’s perfect for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with yours. This will help you tailor your responses and show them you’re not just another candidate, but someone who genuinely fits into their team.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online platforms to get comfortable with common questions. The more you practice, the more confident you’ll feel when it’s time to shine in front of the hiring team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged with our brand. So go ahead, register your interest and let’s get the ball rolling!
We think you need these skills to ace Regulatory & Submissions Lead (Clinical Operations Manger) - London, UK, Hybrid - FSP - REGISTE[...] in Uxbridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory & Submissions Lead role. Highlight your experience with local EC and RA submissions, and don’t forget to mention your familiarity with XML completion. We want to see how your skills match what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role and how your background makes you a perfect fit. We love seeing enthusiasm and a personal touch, so let your personality come through.
Showcase Relevant Experience: When filling out your application, be sure to showcase your relevant experience in preparing submissions and managing IMP supplies. We’re keen on candidates who understand the local regulatory environment, so make that clear!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy and straightforward – just follow the prompts!
How to prepare for a job interview at Parexel
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of local EC and RA submission processes. Familiarise yourself with XML completion and be ready to discuss your experience in preparing submissions, as this will show you're the right fit for the role.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed submissions and compliance. Highlight your understanding of ICH/GCP guidelines and how you've navigated the regulatory landscape in previous projects.
✨Understand the Company Culture
Research Parexel's values and work environment. Be ready to discuss how your passion aligns with their commitment to empowering employees and fostering long-term career development. This will demonstrate that you're not just looking for a job, but a place to grow.
✨Ask Insightful Questions
Prepare thoughtful questions about the role and the team you'll be working with. Inquire about the challenges they face in submissions and how you can contribute to overcoming them. This shows your genuine interest and proactive mindset.