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- Tasks: Lead global regulatory strategy and manage submissions for innovative biotech projects.
- Company: Dynamic biotech firm focused on cutting-edge clinical-stage developments.
- Benefits: Competitive salary, hands-on role, and opportunity for real impact.
- Other info: Fast-paced environment with opportunities for growth and visibility.
- Why this job: Join a high-impact team and shape the future of biotechnology.
- Qualifications: Experience in Regulatory Affairs and familiarity with clinical trial applications.
The predicted salary is between 60000 - 80000 £ per year.
I’m working with an innovative, growing biotech who are looking to bring in a Senior Manager, Regulatory Affairs to support their clinical-stage pipeline. This is a hands-on role in a lean environment, ideal for someone who enjoys working close to the science and taking ownership across both strategy and execution.
You’ll be supporting global regulatory activities across early to mid-stage development programs, working cross-functionally with CMC, clinical, and non-clinical teams.
What you’ll be doing:
- Supporting and contributing to global regulatory strategy
- Preparing and managing regulatory submissions (INDs, CTAs, amendments)
- Working closely with internal teams and external partners to ensure alignment across development activities
- Supporting interactions with health authorities across the US, UK, and EU
- Providing regulatory input into study design, protocols, and development plans
- Tracking regulatory requirements and supporting compliance activities
What they’re looking for:
- Experience in Regulatory Affairs within biotech/pharma
- Strong exposure to clinical trial applications and regulatory submissions
- Understanding across CMC, clinical, and non-clinical components
- Ability to work independently and manage multiple priorities
- Comfortable in a fast-paced, evolving environment
- Experience in advanced therapies, biologics, or complex products would be beneficial, but not essential.
This is a great opportunity to join a small, high-impact team where you’ll have real visibility and ownership.
Senior Manager, Regulatory Affairs in Portsmouth employer: Advanced Clinical
Contact Detail:
Advanced Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, Regulatory Affairs in Portsmouth
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and regulatory affairs space. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of regulatory submissions and global strategies. Be ready to discuss how you’ve contributed to similar projects in the past. Show them you’re not just a fit for the role, but a perfect match for their team!
✨Tip Number 3
Don’t forget to showcase your hands-on experience! In a lean environment, they’ll want to see that you can take ownership and drive projects forward. Use specific examples from your past roles to illustrate your ability to manage multiple priorities effectively.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive and engaged. Make sure to highlight your unique skills and experiences that align with the role!
We think you need these skills to ace Senior Manager, Regulatory Affairs in Portsmouth
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that align with the Senior Manager, Regulatory Affairs role. Highlight your experience in regulatory submissions and any relevant biotech or pharma background to catch our eye!
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 experience can contribute to our innovative team. Don’t forget to mention your ability to work cross-functionally!
Showcase Your Hands-On Experience: Since this role is hands-on, be sure to include examples of when you've taken ownership of projects or strategies in your previous roles. We love seeing candidates who thrive in a lean environment and can juggle multiple priorities!
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people!
How to prepare for a job interview at Advanced Clinical
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially in the biotech sector. Be ready to discuss your experience with INDs, CTAs, and any other relevant submissions. This will show that you’re not just familiar with the basics but can also dive deep into the specifics.
✨Showcase Your Cross-Functional Skills
Since this role involves working closely with CMC, clinical, and non-clinical teams, be prepared to share examples of how you've successfully collaborated across different functions. Highlight any projects where you took ownership and drove alignment among diverse teams.
✨Prepare for Regulatory Scenarios
Think about potential regulatory scenarios you might face in this role and how you would handle them. This could include preparing for health authority interactions or managing compliance activities. Being able to articulate your thought process will demonstrate your strategic thinking.
✨Embrace the Fast-Paced Environment
This position is in a lean, evolving environment, so be ready to discuss how you manage multiple priorities and adapt to change. Share specific examples from your past roles where you thrived under pressure and delivered results despite tight deadlines.