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- Tasks: Lead regulatory affairs for EU products and manage a dynamic team of 3.
- Company: Join a growing specialty pharmaceutical business focused on CNS products.
- Benefits: Competitive salary, bonus, generous leave, and private healthcare.
- Why this job: Make a real impact in regulatory affairs while driving product development and compliance.
- Qualifications: 8+ years in pharma, strong regulatory knowledge, and team leadership skills.
- Other info: Hybrid role with excellent career growth opportunities in a supportive environment.
The predicted salary is between 60000 - 84000 £ per year.
Overview
Job Title: Regulatory Affairs Team Lead (UK/EU)
Job Type: Full-time, Permanent
Remuneration: Up to £70,000 + 7.5% Bonus
An opportunity working for a growing speciality pharmaceutical business that focuses on CNS products and hospital injectables as a Regulatory Affairs Team Lead/Manager. The role reports to the Director of Regulatory Affairs.
This role is ideal for someone with a strong understanding of regulatory frameworks, excellent attention to detail, and the ability to work cross-functionally to support product development and approvals. You will manage a team of 3 officers.
This role plays a pivotal part in driving regulatory support for EU operations, contributing to company financial targets and growth. It includes harmonising regulatory efforts for EU products of the UK portfolio, with MAH under UK portfolio while regulatory oversight remains with UK team post-Brexit.
Additionally, supports in-licensing and acquisitions across UK and EU by collaborating with BD. Provides essential support for new product development initiatives and geographic expansion in UK and EU by aligning with commercial strategies.
Maintains a diverse portfolio of in-house manufacturing and contract manufacturing organisations for UK and EU, ensuring regulatory compliance and overseeing product lifecycle management.
Day-to-day responsibilities
- Portfolio Management: Specialise in managing regulatory affairs for EU products within the portfolio, ensuring adherence to regulations and standards.
- Gap Analysis: Assess Marketing Authorisation vs manufacturing documents to identify discrepancies.
- New MA Applications: Lead preparation and submission of new MA applications in the EU via National, Mutual Recognition, and Decentralised Procedures.
- Geographical Expansion: Drive expansion into other EU markets by navigating regulatory requirements.
- RA Support for New Product Development: Provide regulatory guidance to ensure EU compliance from outset.
- In-licensing Support: Regulatory support for in-licensing activities, integrating acquired products.
- MA Compliance Maintenance: Ensure ongoing compliance and maintenance of MA for assigned portfolio and oversee team.
- Safety Variations: Ensure safety variations in line with reference products, PRAC recommendations, and internal updates; oversee team submissions.
- Change Control Management: Manage regulatory change controls, CAPAs, deviations; SAP familiarity preferred.
- Implementation of PILs and Mock-ups: Oversee PILs and mock-ups implementation, finalising procedural aspects, national phases, artwork coordination.
Skills/Experience
- Experience in the pharmaceutical industry, minimum 8 years.
- Experience in a global matrix organisation and collaboration with external authorities and partners.
- Mutual Recognition and Decentralised Procedures.
- Philosophy that Regulatory Affairs is value-adding, not a bureaucratic function.
- Commercial sense with commitment to high regulatory standards.
- Planning, analytical and decision-making abilities with strategic vision and results-orientation, attention to detail.
- Salary note: competitive salary up to 75k.
- 25 days annual leave, rising to 30 with length of service + bank holidays (prorated).
- Holiday Buy/Sell – up to 5 days.
- 7.5% Bonus – discretionary scheme (policy eligibility).
- Bravo Benefits Platform with discounts, wellbeing support, and more.
- Salary Sacrifice for Electric vehicles with Tusker (policy eligibility).
- Private Healthcare with Medicash health cash plan.
Working hours
- Monday – Friday 37.5 hours per week, hybrid role.
This role does not offer sponsorship; you MUST be based in the UK and hold full right to work. You MUST be able to get to the site 3x per week.
For more information, please reach out to lucy.kirkaldy@cpl.com
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Science, Product Management, and Quality Assurance
Industries
- Pharmaceutical Manufacturing and Biotechnology Research
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Regulatory Affairs Manager employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups related to regulatory affairs. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Show Off Your Expertise
When you get the chance to chat with potential employers, don’t hold back on showcasing your knowledge of regulatory frameworks and compliance. Share specific examples of how you've navigated challenges in past roles to demonstrate your value.
✨Tailor Your Approach
Every company is different, so make sure to tailor your conversations and follow-ups to align with their specific needs and values. Research their recent projects or challenges in regulatory affairs and bring them up to show you're genuinely interested.
✨Apply Through Our Website
Don’t forget to check out our website for the latest job openings! Applying directly through us not only shows your enthusiasm but also helps you stand out in the application process. Let’s get you that dream role!
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience in managing regulatory frameworks and any specific projects that align with the job description. We want to see how your background fits perfectly with what we’re looking for!
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 team. Don’t forget to mention your experience with EU regulations and any leadership roles you've held.
Showcase Your Attention to Detail: In regulatory affairs, attention to detail is key. When writing your application, ensure there are no typos or errors. We appreciate candidates who take the time to present their work meticulously, as it reflects the standards we uphold at StudySmarter.
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. Plus, you’ll find all the details about the role and our company culture there!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulatory Frameworks
Make sure you brush up on the specific regulatory frameworks relevant to the role, especially those pertaining to EU and UK regulations. Being able to discuss these confidently will show that you’re not just familiar with the basics but have a deep understanding of what’s required in this position.
✨Showcase Your Team Management Skills
Since this role involves managing a team, be prepared to share examples of how you've successfully led teams in the past. Highlight your leadership style and how you foster collaboration, especially in cross-functional settings. This will demonstrate your capability to manage and motivate your team effectively.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific regulatory challenges or discrepancies in documentation. Practise articulating your thought process and decision-making strategies in these scenarios, as it will showcase your analytical skills and strategic vision.
✨Align with Company Values
Research the company’s philosophy on regulatory affairs being a value-adding function. Be ready to discuss how your approach aligns with this mindset and how you can contribute to their growth and compliance goals. This will help you stand out as a candidate who fits well with their culture.
