Manager / Senior Manager, Regulatory Affairs – Oncology Biotech
Remote from UK/Ireland.
A fast-growing commercial-stage oncology biotech developing innovative Oncology therapies that address areas of high unmet medical need. As they prepare for the next phase of growth, including thier first US and EU marketing applications, they are seeking a Manager / Senior Manager, Regulatory Affairs to join our team.
This is a unique opportunity to play a key operational role in our regulatory affairs group while gaining hands-on experience across the full drug development lifecycle in oncology.
Key Responsibilities
* Lead and support EU CTR and UK MHRA clinical trial applications in collaboration with CROs.
* Manage day-to-day regulatory operations, including submissions, archiving, and project tracking.
* Contribute to preparation for upcoming marketing authorization applications (US/EU).
* Support global submissions (US, Canada, Latin America) as needed.
* Ensure compliance with regulatory requirements and internal processes while maintaining accurate documentation.
* Depending on background and interest, contribute to strategic regulatory discussions.
Candidate Profile
* 3+ years of EU/EMA regulatory affairs experience (clinical or operations), with strong knowledge of EU CTR requirements.
* Bachelor’s or advanced degree in a life science discipline.
* Background in oncology (clinical practice or regulatory) strongly preferred.
* Highly proficient with MS Office and electronic documentation systems (e.g., SharePoint, Veeva).
* Strong written and verbal communication skills in English.
* Experience with Regulatory CMC, marketing authorization applications, and/or US FDA submissions is a significant advantage.
Why Join them?
* Opportunity to work on first-in-class oncology therapies at a pivotal stage of development.
* Exposure to both clinical and commercial regulatory projects across multiple regions.
* Collaborative, agile biotech culture with significant scope for growth and mentorship.
* Chance to develop both operational and strategic regulatory experience.