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

ProPharma; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading consulting firm is seeking a skilled Regulatory Affairs Project lead to support Clinical trial applications within the EU. This fully remote position requires strong experience in Regulatory Affairs and project management within the life sciences. Successful candidates will have a BSc or higher and a thorough understanding of EU regulations. This is a full-time position expected to start in January 2026, initially lasting for at least 6 months with a possibility of extension.

Qualifications

• Education in life science discipline to at least a BSc.
• Proven experience in Regulatory Affairs and Clinical trial applications.
• Demonstrable project management experience.

Responsibilities

• Provide guidance as a project leader in the Regulatory Affairs CTA group.
• Work with stakeholders for project success.
• Lead preparation and submission of regulatory applications.
• Ensure compliance with EU CTR regulations.
• Achieve project timelines and milestones.

Skills

Project management skills

Knowledge of EU regulations

Fluency in English

Education

BSc or higher in life science

Job description

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 anywhere 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

• 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 onto 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

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.