At a Glance
- Tasks: Lead regulatory operations for innovative oncology therapies and manage submissions across multiple regions.
- Company: Fast-growing biotech focused on developing first-in-class oncology treatments.
- Benefits: Remote work, collaborative culture, and opportunities for growth and mentorship.
- Other info: Dynamic environment with exposure to both clinical and commercial regulatory projects.
- Why this job: Play a key role in shaping the future of oncology therapies and gain hands-on experience.
- Qualifications: 3+ years in EU regulatory affairs with a strong background in oncology preferred.
The predicted salary is between 48000 - 72000 € per year.
Senior Manager, Regulatory Affairs
Remote – United Kingdom
A growing clinical-stage biotech is looking to appoint a Senior Manager, Regulatory Affairs to support global Oncology development programs and European Regulatory activities.
This role will have a strong focus on supporting and executing European/regional Regulatory strategy, partnering closely with cross-functional teams to drive submissions and support key development milestones.
Key Responsibilities:
• Support European and regional Regulatory strategy across development programs
• Act as a key Regulatory representative within cross-functional project teams
• Lead and coordinate regulatory submissions including CTAs, INDs, amendments and marketing applications
• Coordinate contributors across CTD Modules 1–5 and manage submission timelines
• Ensure submissions are high quality, compliant and eCTD-ready
• Support Health Authority responses and post-approval lifecycle activities
Requirements:
• Degree in Life Sciences or related discipline
• 6+ years’ Regulatory Affairs within biotech or pharma
• Experience supporting clinical trial and marketing applications
• Late-stage development and Oncology experience desirable
• Strong understanding of CTD/eCTD submissions
• Excellent organisational skills and attention to detail
Senior Manager Regulatory Affairs employer: Regulatory Connect
Join a fast-growing oncology biotech that is at the forefront of developing innovative therapies for high unmet medical needs. With a collaborative and agile work culture, this role offers significant opportunities for professional growth and mentorship, allowing you to gain hands-on experience across the full drug development lifecycle. As part of a dynamic team, you'll play a key role in shaping the future of oncology treatments while working remotely from the UK or Ireland.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those with oncology experience. Use platforms like LinkedIn to connect and engage with them; you never know who might have a lead on your dream job!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU CTR and UK MHRA requirements. Be ready to discuss how your experience aligns with the role and demonstrate your understanding of the drug development lifecycle in oncology.
✨Tip Number 3
Showcase your skills! Create a portfolio that highlights your past regulatory submissions and projects. This will not only impress potential employers but also give you confidence when discussing your achievements during interviews.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got some fantastic opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, it’s a great way to show your enthusiasm for joining our team!
We think you need these skills to ace Senior Manager Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Senior Manager in Regulatory Affairs. Highlight your experience with EU CTR and UK MHRA applications, as well as any oncology-specific knowledge you have. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs in oncology and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Communication Skills:Strong written communication is key in this role. Make sure your application is clear, professional, and free of errors. We appreciate attention to detail, so take the time to proofread before hitting send!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Regulatory Connect
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of EU CTR and UK MHRA requirements. Be ready to discuss specific examples from your past experience that demonstrate your understanding of regulatory processes, especially in oncology.
✨Showcase Your Communication Skills
Since strong written and verbal communication skills are crucial for this role, prepare to articulate your thoughts clearly. Practice explaining complex regulatory concepts in simple terms, as you might need to do this with cross-functional teams.
✨Demonstrate Your Project Management Prowess
Be prepared to talk about how you've managed regulatory submissions and project tracking in the past. Highlight any tools or systems you've used, like SharePoint or Veeva, to keep everything organised and compliant.
✨Express Your Passion for Oncology
This role is all about making a difference in oncology. Share your enthusiasm for the field and any relevant experiences that fuel your passion. Whether it's through clinical practice or regulatory work, let them know why oncology matters to you.
