At a Glance
- Tasks: Lead regulatory strategy and submissions for innovative oncology programs.
- Company: Rapidly growing biotech with a strong pipeline and collaborative culture.
- Benefits: Competitive salary, bonus, equity, and remote work options.
- Other info: Fast-paced environment with excellent growth opportunities.
- Why this job: Make a real impact in global oncology development while advancing your career.
- Qualifications: 6-10 years in Regulatory Affairs with strong EU submission experience.
The predicted salary is between 80000 - 100000 £ per year.
A rapidly growing, clinical-stage biotech is expanding its European Regulatory team and is looking to appoint an Associate Director, Regulatory Affairs to support global Oncology development programs, with a focus on EU strategy and submissions.
The Role
- Support and contribute to regulatory strategy across clinical-stage programs
- Lead preparation and submission of CTA/MAA and lifecycle activities to EMA and other health authorities.
- Partner with cross-functional teams to ensure regulatory requirements are integrated into development plans.
- Support interactions with health authorities (briefing packages, responses, submissions).
- Ensure compliance with EU regulations, ICH guidelines, and GxP standards.
- Contribute to regulatory documentation and support submission delivery timelines.
Requirements
- 6–10 years’ experience in Regulatory Affairs (biotech/pharma)
- Experience leading clinical Regulatory strategy
- Strong experience with EU regulatory submissions (CTA/MAA)
- Oncology experience is highly desired.
- Experience with expedited regulatory pathways/designations, e.g., ODD, BT, AA, etc.
- Strong communication skills and ability to work cross-functionally
- Degree in Life Sciences (advanced degree a plus)
Why Join?
- Key role in a growing biotech with a strong pipeline
- Opportunity to work across EU and global programs
- Collaborative, fast-paced environment with real impact on development programs
- Competitive package + bonus + equity
Locations
Associate Director Regulatory Affairs in Hampshire, Portsmouth employer: Regulatory Connect
Join a rapidly growing clinical-stage biotech that offers a unique opportunity to shape the future of Oncology development in a collaborative and fast-paced environment. With a strong focus on employee growth, you will be part of a team that values innovation and compliance, while enjoying a competitive package that includes bonuses and equity. This role not only allows you to contribute to impactful global programs but also fosters a culture of partnership across cross-functional teams, making it an excellent employer for those seeking meaningful and rewarding work.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director Regulatory Affairs in Hampshire, Portsmouth
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs space, especially those with experience in oncology. 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 EU regulations and recent developments in biotech. We recommend creating a cheat sheet of key topics 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 openings that match your skills in regulatory affairs, and tailor your approach to each opportunity.
✨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 Associate Director Regulatory Affairs in Hampshire, Portsmouth
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Associate Director Regulatory Affairs role. Highlight your experience in regulatory strategy and EU submissions, especially in oncology. 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 growing biotech. Keep it concise but impactful – we love a good story!
Showcase Your Experience:When detailing your experience, focus on specific achievements in regulatory submissions and interactions with health authorities. We’re looking for evidence of your ability to lead and collaborate across teams, so don’t hold back!
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 this exciting opportunity. Plus, it’s super easy – just a few clicks!
How to prepare for a job interview at Regulatory Connect
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of EU regulations, ICH guidelines, and GxP standards. Be ready to discuss how your experience aligns with the requirements for CTA/MAA submissions and any expedited pathways you've worked with.
✨Showcase Your Leadership Skills
Since this role involves leading regulatory strategy, prepare examples of how you've successfully led teams or projects in the past. Highlight your ability to partner with cross-functional teams and ensure compliance throughout the development process.
✨Prepare for Health Authority Interactions
Think about your previous experiences interacting with health authorities. Be ready to discuss specific instances where you prepared briefing packages or responded to submissions, showcasing your communication skills and strategic thinking.
✨Demonstrate Your Passion for Oncology
If you have oncology experience, make it a focal point in your interview. Share your insights on current trends in the field and how they relate to regulatory affairs. This will show your genuine interest and commitment to the area.
