At a Glance
- Tasks: Support regulatory activities for EU and US, ensuring submission readiness and compliance.
- Company: Leading Regulatory Affairs consultancy with a focus on innovation.
- Benefits: Remote work, competitive pay, and flexible contract outside IR35.
- Other info: Great opportunity for career growth in a supportive environment.
- Why this job: Join a dynamic team and make a real impact in regulatory affairs.
- Qualifications: Experience in clinical regulatory and operational submissions required.
The predicted salary is between 50000 - 70000 € per year.
A leading Regulatory Affairs consultancy is looking for an experienced regulatory professional to support one of the Regulatory Strategy Leads across EU and US development activities. The role requires a hands-on individual with a strong clinical regulatory background, operational submission experience, and working knowledge of both EMA centralised procedures and FDA regulatory requirements. This is a remote, outside IR35 contract job in Regulatory Affairs.
Your new role
- Regulatory Operational Support
- Provide operational regulatory support to the assigned Regulatory Strategy Lead.
- Support EU and US development regulatory activities across ongoing programmes.
- Coordinate regulatory timelines, deliverables, and submission readiness activities.
- Track and manage regulatory actions, commitments, and submission milestones.
- Support internal governance and cross-functional coordination activities.
- Clinical Regulatory Documentation
- Perform hands-on preparation, review, formatting, and maintenance of regulatory documentation.
- Support updates to clinical and regulatory documents in line with authority expectations.
- Coordinate document version control and ensure submission-ready quality standards.
- Support authoring coordination activities across internal stakeholders and external vendors where applicable.
- EU Centralised Procedure Support
- Provide operational support for EMA centralised procedure activities.
- Assist with dossier compilation and submission coordination.
- Support life cycle management activities associated with development submissions.
- Ensure alignment of submission documentation with EU regulatory requirements and timelines.
- FDA Regulatory Support
- Support US regulatory operational activities and FDA-related documentation requirements.
- Assist with submission preparation and document management activities for US filings.
- Coordinate responses, updates, and submission components in collaboration with the Regulatory Strategy Lead.
What you'll need to succeed
What you'll get in return
Remote working, outside IR35 rate.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Regulatory Affairs Consultant EU and US in Uxbridge employer: Hays Life Sciences
As a leading Regulatory Affairs consultancy, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to excel in their roles. With the flexibility of remote working and a focus on professional development, we offer our team members the opportunity to engage in meaningful projects that directly impact regulatory strategies across the EU and US. Join us to be part of a dynamic environment where your expertise is valued and your career can thrive.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Consultant EU and US in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who have experience with EMA and FDA processes. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory submissions and timelines. Be ready to discuss your hands-on experience with clinical documentation and how you’ve managed regulatory actions in past roles.
✨Tip Number 3
Don’t forget to showcase your organisational skills! Highlight how you’ve coordinated deliverables and maintained submission readiness in previous positions. This will show potential employers that you can handle the operational support they need.
✨Tip Number 4
Apply through our website for the best chance at landing the role! We’re always looking for talented individuals like you, so make sure your application stands out by tailoring it to the specific requirements of the job.
We think you need these skills to ace Regulatory Affairs Consultant EU and US in Uxbridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in regulatory affairs, especially focusing on EU and US regulations. We want to see how your background aligns with the specific requirements mentioned in the job description.
Showcase Relevant Experience:When writing your application, emphasise your hands-on experience with clinical regulatory documentation and operational submissions. We love seeing concrete examples of how you've successfully managed regulatory timelines and deliverables.
Be Clear and Concise:Keep your application clear and to the point. Use bullet points where possible to make it easy for us to read through your qualifications and experiences. We appreciate a straightforward approach that gets right to the heart of your skills.
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 makes the whole process smoother for everyone involved.
How to prepare for a job interview at Hays Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on both EMA and FDA regulations before the interview. Familiarise yourself with recent changes and how they impact submission processes. This will show that you're not just experienced, but also current in your knowledge.
✨Showcase Your Hands-On Experience
Prepare specific examples of your past work in regulatory affairs, especially any operational submission experiences. Be ready to discuss how you've managed timelines and deliverables in previous roles, as this is crucial for the position.
✨Demonstrate Cross-Functional Coordination Skills
Think of instances where you've successfully collaborated with different teams or stakeholders. Highlight your ability to coordinate activities and manage document version control, as these skills are key for the role.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory strategies and how they handle EU and US submissions. This shows your genuine interest in the role and helps you understand their expectations better.
