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 late-stage development and Oncology.
- Why this job: Make a real impact in the biotech field and drive key development milestones.
- Qualifications: Degree in Life Sciences and 6+ years in Regulatory Affairs.
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, Data Management employer: Regulatory Connect
Join a dynamic and innovative clinical-stage biotech company that prioritises employee growth and collaboration. With a strong focus on Oncology development, we offer a supportive work culture that encourages professional development through cross-functional teamwork and impactful projects. Our remote working model provides flexibility while ensuring you are part of a passionate team dedicated to advancing healthcare solutions.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Data Management
✨Tip Number 1
Network like a pro! Reach out to professionals in the biotech and pharma sectors, especially those with experience in Regulatory Affairs. 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 European regulatory strategies and CTD/eCTD submissions. We recommend creating a cheat sheet of key points to discuss, so you can confidently showcase your expertise during the interview.
✨Tip Number 3
Don’t just apply anywhere—focus on companies that align with your values and career goals. Check out our website for tailored job listings that match your skills in Regulatory Affairs, and make sure to apply directly through us for the best chance!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in leaving a positive impression. It shows your enthusiasm for the role and keeps you fresh in their minds as they make their decision.
We think you need these skills to ace Senior Manager, Data Management
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 development programmes. 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 goals 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 to join 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 specific examples from your past experience that demonstrate your expertise in these areas.
✨Showcase Your Cross-Functional Skills
Since this role involves working closely with various teams, prepare to share instances where you've successfully collaborated with cross-functional groups. Highlight how you coordinated efforts and drove submissions to meet key milestones.
✨Be Detail-Oriented
Given the importance of high-quality submissions, be prepared to talk about how you ensure compliance and attention to detail in your work. You might want to mention any systems or processes you use to maintain quality in your submissions.
✨Prepare for Health Authority Scenarios
Think about potential questions related to Health Authority responses and post-approval activities. Have a few examples ready that showcase your ability to navigate these situations effectively and how you’ve handled challenges in the past.
