Freelance/Contract Regulatory Affairs Project Manager - Clinical trial applications (CTA's)

Company profile

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. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Job description

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 projects 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

#LI-DNI

Additional Information

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.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***