At a Glance
- Tasks: Lead regulatory submissions and support global Oncology development programmes.
- Company: Dynamic clinical-stage biotech focused on innovative therapies.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on career advancement.
- Why this job: Make a real impact in the biotech field and shape future treatments.
- Qualifications: 6+ years in Regulatory Affairs with a degree in Life Sciences.
The predicted salary is between 60000 - 80000 £ per year.
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 in Newcastle upon Tyne employer: Regulatory Connect
Join a dynamic and innovative clinical-stage biotech that prioritises employee growth and collaboration in the heart of the UK's thriving life sciences sector. With a strong commitment to fostering a supportive work culture, we offer competitive benefits, flexible working arrangements, and opportunities for professional development, making it an ideal environment for those passionate about advancing Oncology therapies. Be part of a team that values your expertise and contributions as we drive impactful regulatory strategies together.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Regulatory Affairs in Newcastle upon Tyne
✨Tip Number 1
Network like a pro! Reach out to professionals in the Regulatory Affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Senior Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of European regulatory strategies and recent developments in Oncology. We want you to shine when discussing your experience with CTD/eCTD submissions!
✨Tip Number 3
Showcase your organisational skills! During interviews, share specific examples of how you've managed submission timelines and coordinated cross-functional teams. We love hearing about your attention to detail!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re excited to see how you can contribute to our growing team in Regulatory Affairs.
We think you need these skills to ace Senior Manager Regulatory Affairs in Newcastle upon Tyne
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Manager, Regulatory Affairs role. Highlight your experience in regulatory submissions and any specific oncology projects you've worked on. 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 and how your skills can help us drive our European regulatory strategy. Keep it concise but impactful!
Showcase Your Teamwork Skills:Since this role involves working closely with cross-functional teams, make sure to highlight your collaboration skills. Share examples of how you've successfully partnered with others to achieve regulatory milestones in your previous roles.
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 European regulatory strategies and CTD/eCTD submissions. Be ready to discuss your past experiences in detail, especially any late-stage development or oncology projects you've worked on.
✨Showcase Your Team Spirit
This role involves working closely with cross-functional teams, so be prepared to share examples of how you've successfully collaborated in the past. Highlight your ability to lead and coordinate efforts across different contributors.
✨Be Detail-Oriented
Given the importance of high-quality submissions, demonstrate your attention to detail. You might want to mention specific instances where your organisational skills made a difference in meeting submission timelines or ensuring compliance.
✨Prepare for Health Authority Interactions
Since you'll be supporting Health Authority responses, think about any relevant experiences you have in this area. Be ready to discuss how you handled challenging questions or situations during previous interactions.
