At a Glance
- Tasks: Lead regulatory strategies for oncology products and guide them through approval processes.
- Company: Join a global biotech company dedicated to transforming cancer treatment.
- Benefits: Enjoy hybrid work options and a collaborative team environment.
- Why this job: Make a real impact on patients' lives while working in an innovative culture.
- Qualifications: Proven experience in regulatory affairs for clinical-stage products in the EU and US.
- Other info: This is a 12-month contract with potential for extension.
The predicted salary is between 43200 - 72000 £ per year.
A global biotechnology company is seeking a visionary Regulatory Affairs Senior Manager to drive their expanding oncology portfolio from a strategic perspective. You will play a pivotal role in bringing life-changing cancer treatments from development to patient delivery across EU markets. You will craft regulatory strategies that navigate complex approval pathways and build crucial relationships with health authorities.
Your Expertise & Impact
- Lead development and execution of regulatory strategies for clinical-stage oncology products
- Lead EU CTR Submission strategies
- Guide products through critical regulatory milestones from early development to market approval
- Foster collaborative relationships with health authorities
- Provide strategic regulatory guidance to cross-functional teams
I am looking for a strategic thinker with proven experience developing and implementing regulatory strategies for clinical-stage products in the EU and US. Experience with Scientific Advice, PIPs, and ODDs will help you hit the ground running.
Location & Benefits
This 12-month contract (with potential extension) offers hybrid work with monthly team meetings in Uxbridge/Cambridge. Join a company that values innovation, collaboration, and making a real difference in patients' lives.
Apply now by submitting your CV, or reach out to Julia Bowden to discuss this opportunity further.
Senior Manager Regulatory Affairs EU Oncology in Uxbridge employer: Hays
Contact Detail:
Hays Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Regulatory Affairs EU Oncology in Uxbridge
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in oncology. Attend industry conferences or webinars to connect with key players and gain insights into the latest trends and challenges in EU regulatory processes.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and guidelines for oncology products in the EU. Understanding the nuances of Clinical Trial Regulations (CTR) and how they apply to your potential role will demonstrate your commitment and expertise during discussions.
✨Tip Number 3
Prepare to discuss your previous experiences in leading regulatory strategies for clinical-stage products. Be ready to share specific examples of how you navigated complex approval pathways and built relationships with health authorities, as this will showcase your strategic thinking and leadership skills.
✨Tip Number 4
Research the company’s current oncology portfolio and any recent developments in their regulatory submissions. This knowledge will not only help you tailor your conversations but also show your genuine interest in contributing to their mission of delivering life-changing treatments.
We think you need these skills to ace Senior Manager Regulatory Affairs EU Oncology in Uxbridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly in oncology. Emphasise your strategic thinking and any specific achievements related to EU regulatory processes.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for oncology and your understanding of the regulatory landscape. Mention specific experiences that demonstrate your ability to navigate complex approval pathways.
Highlight Collaborative Skills: In your application, emphasise your ability to foster relationships with health authorities and cross-functional teams. Provide examples of how you've successfully collaborated in previous roles.
Showcase Relevant Knowledge: Demonstrate your knowledge of Scientific Advice, PIPs, and ODDs in your application. This will show that you are well-prepared to hit the ground running in this role.
How to prepare for a job interview at Hays
✨Understand the Regulatory Landscape
Familiarise yourself with the current EU regulatory framework for oncology products. Be prepared to discuss recent changes and how they might impact the company's strategies.
✨Showcase Your Strategic Thinking
Prepare examples of how you've developed and executed regulatory strategies in the past. Highlight your ability to navigate complex approval pathways and your experience with Scientific Advice, PIPs, and ODDs.
✨Build Rapport with Health Authorities
Demonstrate your experience in fostering relationships with health authorities. Share specific instances where your collaborative approach led to successful outcomes in regulatory submissions.
✨Engage with Cross-Functional Teams
Illustrate your ability to provide strategic regulatory guidance to cross-functional teams. Discuss how you’ve worked with different departments to ensure alignment on regulatory goals and milestones.