At a Glance
- Tasks: Lead regulatory affairs for clinical trial applications and ensure compliance with EU regulations.
- Company: Join ProPharma, the world's largest Research Consulting Organization, making a real impact in life sciences.
- Benefits: Fully remote work, flexible hours, and opportunities for project extension.
- Other info: Diversity and inclusion are at our core; bring your authentic self to work.
- Why this job: Be part of groundbreaking projects that advance health and wellness globally.
- Qualifications: BSc in life sciences and proven experience in regulatory affairs for clinical trials.
The predicted salary is between 36000 - 60000 £ per year.
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.
ProPharma is continuing to be an integral partner of a global life-sciences brand as they require project support within their Regulatory Affairs group within the EU. This role in particular is to act as a Regulatory Affairs Project for their Clinical trial applications (CTA's) within the EU space with demonstrated experience in the area being a must. The project will commence in January 2026; it is a full-time position (1.0 FTE) and can be performed fully remotely throughout anyway within the UK or EU. It will run for at least 6 months initially but with a high chance of extending and we would prefer support from an independent consultant.
Responsibilities included:
- Provide guidance and support as a project leader on a cross functional basis within the Regulatory Affairs CTA group
- Work effectively with various stakeholders to ensure each project's success
- Lead the preparation, review and submit regulatory clinical trial applications within the EU
- Ensure all submission activities meet key regulations within the region
- Ensure compliance is achieved to the EU CTR regulations throughout each project
- Implement and submit key documentation on to our clients systems
- Provide key project leadership across a range of groups
- Ensure all timelines and milestones are achieved throughout the project
- Overall support our client with strategic and operational goals within the Regulatory Affairs CTA space
Skills required:
- Must be educated within a life science discipline to at least a BSc or higher
- Proven experience working within Regulatory Affairs linked to Clinical trial applications is a must
- Can demonstrate key project management skills within a similar setting
- Thorough experience working to all key regulations within the EU
- Strategic and operational skills within the area are a must
- Fluency in English is a must
- Can perform the project to the requirements set out within the job description
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
Freelance/Contract Regulatory Affairs Project Manager - Clinical trial applications (CTA\'s) in Oxford employer: ProPharma
ProPharma is an exceptional employer that champions innovation and collaboration, offering a fully remote work environment across the UK and EU. With a strong commitment to diversity, equity, and inclusion, employees are empowered to thrive in their roles while contributing to meaningful advancements in healthcare. The company provides ample opportunities for professional growth within the dynamic field of regulatory affairs, making it an ideal choice for those seeking impactful and rewarding careers.
StudySmarter Expert Advice🤫
We think this is how you could land Freelance/Contract Regulatory Affairs Project Manager - Clinical trial applications (CTA\'s) in Oxford
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs space, especially those who have experience with clinical trial applications. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Show off your expertise! When you get the chance to chat with potential employers, make sure to highlight your experience with EU regulations and project management. We want to see how you can lead projects to success!
✨Tip Number 3
Be proactive! Don’t just wait for job postings to pop up. Reach out directly to companies like ProPharma through our website and express your interest in freelance opportunities. You never know what might come up!
✨Tip Number 4
Prepare for interviews by brushing up on key regulations and compliance issues related to clinical trial applications. We want to see that you’re not just knowledgeable but also passionate about making a difference in the life sciences field!
We think you need these skills to ace Freelance/Contract Regulatory Affairs Project Manager - Clinical trial applications (CTA\'s) in Oxford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Regulatory Affairs Project Manager. Highlight your experience with clinical trial applications and any relevant project management skills. We want to see how your background aligns with what ProPharma is looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Share specific examples of your past experiences in regulatory affairs and how they relate to the job description. Let’s make it personal and engaging!
Showcase Your Skills:Don’t forget to highlight your strategic and operational skills in your application. ProPharma is looking for someone who can lead projects effectively, so make sure we can see that you’ve got what it takes right from the start!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it’s super easy!
How to prepare for a job interview at ProPharma
✨Know Your Regulatory Stuff
Make sure you brush up on the latest EU regulations regarding clinical trial applications. ProPharma is looking for someone who can demonstrate a solid understanding of these regulations, so be prepared to discuss how your experience aligns with their requirements.
✨Showcase Your Project Management Skills
Be ready to share specific examples of your project management experience in regulatory affairs. Highlight any successful projects you've led, focusing on how you managed timelines and collaborated with stakeholders to achieve compliance and success.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific challenges in regulatory affairs. Think about potential scenarios related to clinical trial applications and prepare your responses to show your strategic thinking and problem-solving skills.
✨Emphasise Your Collaborative Spirit
ProPharma values teamwork, so be sure to highlight your ability to work effectively with cross-functional teams. Share examples of how you've successfully collaborated with different stakeholders to drive project success in the past.
