At a Glance
- Tasks: Lead regulatory submissions and support global Oncology development programs.
- Company: Dynamic biotech company focused on innovative cancer treatments.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and excellence.
- Why this job: Make a real impact in the fight against cancer while advancing your career.
- 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 Warrington 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 while driving impactful regulatory strategies.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Regulatory Affairs in Warrington
✨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 showcase your expertise and passion during those crucial conversations!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We recommend checking out our website for tailored opportunities that fit your skills in Regulatory Affairs.
✨Tip Number 4
Follow up after interviews! A simple thank-you email can go a long way in keeping you top of mind. We believe it shows your enthusiasm and professionalism, which are key traits for a Senior Manager.
We think you need these skills to ace Senior Manager Regulatory Affairs in Warrington
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 or late-stage development 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 contribute to our global Oncology development programs. Keep it engaging and relevant to the job description.
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 in past roles to drive submissions and meet key milestones.
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 at StudySmarter!
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 leading regulatory submissions and how you've ensured compliance and quality in your work.
✨Showcase Your Cross-Functional Skills
This role involves working closely with various teams, so be prepared to share examples of how you've successfully collaborated with cross-functional project teams in the past. Highlight your ability to coordinate contributors and manage timelines effectively.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or scenarios. Think about your previous experiences and be ready to explain your thought process and decision-making in those situations.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the company and the role. Inquire about their current projects in Oncology or how they approach regulatory strategy. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.
