At a Glance
- Tasks: Lead regulatory strategy for innovative drug-device combination projects and guide clients through approvals.
- Company: Join a leading organisation in the pharmaceutical and medical technology sector focused on sustainability.
- Benefits: Strategic role with exposure to global projects and opportunities for leadership development.
- Other info: Dynamic environment with opportunities to mentor and manage a growing team.
- Why this job: Make a real impact in a forward-thinking company at the forefront of sustainable technologies.
- Qualifications: 10 years of regulatory experience, strong leadership skills, and a scientific or regulatory degree.
The predicted salary is between 60000 - 80000 £ per year.
Your new company
You will be joining a leading organisation in the pharmaceutical and medical technology sector, specialising in the manufacture of drug-device combination products. The business is recognised for its innovative technologies and its focus on sustainability, working closely with global regulatory bodies and clients.
Your new role
As a Regulatory Manager, you will take on a highly visible, client-facing position, responsible for leading regulatory strategy across drug-device combination product projects. You will provide expert guidance on regulatory pathways, supporting customers in achieving approvals across regions such as the EU and US. Your role will involve leading regulatory aspects of development projects, reviewing and approving key documentation (including DMFs, technical files, and CTD submissions), and acting as a primary point of contact for regulatory agencies such as the MHRA, EMA, and FDA.
As second in command, you will also play a key leadership role, managing a small team with scope to grow, contributing to regulatory intelligence across the business, and representing the regulatory function in senior-level internal and external meetings.
What you'll need to succeed
To be successful in this role, you will ideally have:
- Around 10 years of regulatory experience within pharmaceuticals or medical devices
- Strong experience in drug-device combination product development and successful filings in EU and/or US markets
- Proven ability to lead regulatory projects and manage multiple priorities
- Excellent communication and stakeholder management skills
- A scientific or regulatory degree (or equivalent)
- Background in line management
You will also bring strong leadership capabilities, with experience mentoring or managing teams and working cross-functionally within complex environments.
What you'll get in return
In return, you will have the opportunity to work in a strategic, impactful role within a forward-thinking organisation at the forefront of drug-device combination product manufacturing. You will gain exposure to global regulatory projects, senior stakeholders, and cutting-edge developments in sustainable technologies, alongside opportunities to develop your leadership career.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Regulatory Manager employer: Hays Life Sciences
Join a pioneering organisation in the pharmaceutical and medical technology sector, where innovation meets sustainability. As a Regulatory Manager, you will thrive in a dynamic work culture that values collaboration and professional growth, offering you the chance to lead impactful projects while developing your leadership skills. With exposure to global regulatory landscapes and a commitment to employee development, this role provides a unique opportunity to make a meaningful difference in the industry.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical and medical technology sectors. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on regulatory strategies and recent developments in drug-device combination products. Show that you’re not just knowledgeable but also passionate about the field!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds.
✨Tip Number 4
Apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge over other candidates. Let’s get you that dream job!
We think you need these skills to ace Regulatory Manager
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Manager role. Highlight your regulatory experience, especially in drug-device combination products, and showcase any successful filings you've led in the EU or US markets.
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 leadership skills can contribute to our innovative team at StudySmarter.
Showcase Your Communication Skills:Since this role involves client-facing responsibilities, emphasise your excellent communication and stakeholder management skills. Share examples of how you've effectively communicated with regulatory agencies like the MHRA, EMA, or FDA.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any updates from us!
How to prepare for a job interview at Hays Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines related to drug-device combination products. Familiarise yourself with the specific requirements of agencies like the MHRA, EMA, and FDA, as this will show your expertise and readiness for the role.
✨Showcase Your Leadership Skills
Since this role involves managing a team, be prepared to discuss your leadership style and experiences. Think of examples where you've successfully led projects or mentored team members, as this will highlight your capability to take on a key leadership role.
✨Prepare for Client-Facing Scenarios
As a Regulatory Manager, you'll be interacting with clients regularly. Prepare for questions about how you handle client relationships and manage expectations. Share specific instances where you've navigated complex stakeholder interactions effectively.
✨Demonstrate Your Strategic Thinking
This position requires a strategic mindset, so be ready to discuss how you approach regulatory strategy. Think about how you've contributed to regulatory intelligence in past roles and be prepared to share your insights on future trends in the industry.
