At a Glance
- Tasks: Lead regulatory strategy for innovative drug-device combination products and mentor a dynamic team.
- Company: Global CDMO specialising in complex drug-device combinations with a focus on growth.
- Benefits: Competitive salary, career development opportunities, and a chance to make a real impact.
- Other info: Join a collaborative environment where your expertise drives success and innovation.
- Why this job: Be at the forefront of regulatory affairs in a high-impact role that shapes product development.
- Qualifications: Proven experience with Module 3 documentation and strong client-facing skills required.
The predicted salary is between 60000 - 75000 £ per year.
Cure Talent are delighted to be partnered with a global CDMO specialising in complex drug-device combination products, as they continue to expand their Regulatory Affairs capability following a period of significant growth.
As part of an ongoing reorganisation, the business is growing its regulatory team and appointing a Regulatory Manager to lead project delivery across a diverse portfolio of combination products, with a strong focus on inhalation and respiratory devices. This is a client-facing, hands-on leadership role where you will be responsible for driving regulatory strategy and delivery across multiple projects, acting as the regulatory subject matter expert and primary point of contact for customers and regulatory agencies.
As the Regulatory Manager, you will lead the regulatory aspects of development programmes, contributing to project planning, advising on regulatory pathways and ensuring high-quality submission content, with particular focus on Module 3 authoring. You will work closely with internal teams and external clients, providing clear, confident regulatory guidance and challenging where required to ensure compliant and efficient routes to market. This role combines leadership with delivery. While you will have responsibility for mentoring and developing team members, this is not a role for someone who wants to step away from the detail. You will remain hands-on, owning projects and contributing directly to regulatory documentation and submissions.
To be successful as the new Regulatory Manager, you will bring proven experience authoring Module 3 documentation for drug-device combination products or inhalation / respiratory drug products. You will be confident operating in a client-facing environment, able to define and defend regulatory strategy, and comfortable taking ownership of complex programmes as the regulatory lead.
Key Responsibilities- Lead regulatory strategy and delivery for drug-device combination development programmes.
- Author and review regulatory documentation, with direct ownership of Module 3 content.
- Act as the primary regulatory contact for clients and external regulatory agencies.
- Provide regulatory input into project planning, timelines and resource requirements.
- Review and approve regulatory documentation prepared by Specialists and Associates.
- Support and mentor team members, driving performance and development.
- Contribute to regulatory intelligence and advise on evolving regulatory requirements.
- Represent the regulatory function in client meetings and internal governance forums.
- Proven experience authoring Module 3 documentation as part of regulatory submissions.
- Experience within drug-device combination products or inhalation / respiratory delivery systems.
- Strong understanding of global regulatory requirements for combination products.
- Experience operating in a client-facing or consultancy/CDMO environment is advantageous.
- Ability to manage multiple projects and influence stakeholders at all levels.
- Strong communication skills and confidence in presenting and challenging regulatory strategy.
This is a high-impact role within a growing organisation where Regulatory plays a central role in client delivery and product development. It will suit someone who is comfortable in the detail, confident in front of clients and capable of leading regulatory workstreams end-to-end.
Regulatory Manager in Chorlton employer: CURE TALENT LIMITED
As a global leader in the CDMO sector, this company offers an exceptional work environment for Regulatory Managers, characterised by a collaborative culture that prioritises innovation and professional growth. Employees benefit from hands-on leadership opportunities, mentorship programmes, and the chance to work on cutting-edge drug-device combination products, all while being part of a dynamic team that values regulatory excellence and client engagement.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Manager in Chorlton
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or attend relevant events. We all know that sometimes it’s not just what you know, but who you know that can help you land that Regulatory Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of Module 3 documentation and regulatory strategies. We recommend practising common interview questions with a friend or in front of the mirror to boost your confidence.
✨Tip Number 3
Showcase your hands-on experience! When discussing your past roles, highlight specific projects where you led regulatory strategy or authored key documents. We want to see how you’ve made an impact in previous positions.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Manager in Chorlton
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your experience with Module 3 documentation and any relevant drug-device combination products to catch our eye!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the Regulatory Manager role. Share examples of how you've successfully led regulatory strategies and worked with clients.
Showcase Your Leadership Skills:Since this role involves mentoring and leading a team, don’t forget to mention your leadership experiences. We want to see how you’ve driven performance and development in past roles!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands and shows us you’re serious about joining our team!
How to prepare for a job interview at CURE TALENT LIMITED
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of Module 3 documentation and the specific regulatory requirements for drug-device combination products. Be ready to discuss your past experiences in detail, especially any challenges you've faced and how you overcame them.
✨Showcase Your Leadership Skills
Since this role involves mentoring and leading a team, prepare examples that highlight your leadership style. Think about times when you successfully guided a project or supported a colleague's development. This will show that you're not just about the details but also about empowering others.
✨Client-Facing Confidence
As you'll be the primary contact for clients and regulatory agencies, practice articulating your regulatory strategies clearly and confidently. Role-play potential client scenarios with a friend to get comfortable with presenting and defending your ideas.
✨Prepare for Project Management Questions
Expect questions about how you manage multiple projects and influence stakeholders. Have specific examples ready that demonstrate your organisational skills and ability to juggle competing priorities while maintaining high-quality outputs.
