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- Tasks: Lead regulatory activities for innovative medicines in the UK and Ireland.
- Company: Join a leading global pharmaceutical organisation with a collaborative culture.
- Benefits: Competitive salary, comprehensive benefits, and hybrid working options.
- Why this job: Shape regulatory pathways and make a real impact on patient care.
- Qualifications: 6+ years of UK regulatory experience and strong leadership skills.
- Other info: Opportunity for career progression in a forward-thinking environment.
The predicted salary is between 43200 - 72000 £ per year.
An exciting opportunity has arisen to join a leading global pharmaceutical organisation as the Senior Regulatory Affairs Manager for the UK & Ireland affiliates. In this pivotal role, you will act as the regulatory lead for both markets, overseeing the full spectrum of regulatory activities—from submissions and approvals to ongoing lifecycle management.
This position is ideal for an experienced regulatory professional looking to step into a strategic leadership role where you will shape regulatory pathways, lead an established team, and support the delivery of innovative medicines across the UK and Ireland.
About the Role
As the Senior Regulatory Affairs Manager, you will be accountable for providing regulatory leadership, strategy, and operational oversight for assigned marketed products and development projects. You will lead the UK & Ireland Regulatory Affairs team and act as the primary liaison with Health Authorities, ensuring regulatory compliance and excellence across both markets.
Key Responsibilities
- Health Authority Leadership
- Act as the primary point of contact for the MHRA and HPRA, leading communications, negotiations, and meetings on regulatory matters.
- Lead all affiliate‑level regulatory activities, including regulatory strategy development and pre‑submission engagement with authorities.
- Submissions & Approvals
- Lead and manage timely submissions of Clinical Trial Applications (CTAs) and Marketing Authorisation Applications (MAAs) for the UK and Ireland.
- Led scientific advice with the health authorities and any other critical development activities.
- Evaluate national submission content, ensuring quality, completeness, and compliance with requirements, and identify areas requiring further resolution.
- Oversee the preparation of national documentation, including labelling materials.
- Regulatory Strategy & Collaboration
- Work closely with Global and European Regulatory teams to develop market‑specific regulatory strategies.
- Provide clear regulatory guidance to internal stakeholders and external partners.
- Advise on national submissions, accelerating approval timelines while maintaining compliance.
- Leadership & Team Development
- Lead, mentor, and develop the UK Regulatory Affairs team, promoting high performance and capability development.
- Ensure accurate tracking, reporting, and timely delivery of national regulatory submissions and associated milestones.
- Lifecycle & Compliance Oversight
- Maintain licences for approved products, overseeing variations, renewals, and implementation of changes.
- Ensure ongoing regulatory compliance and proactively update global teams on progress and outcomes.
About You
To succeed in this role, you will bring:
- A Bachelor's degree or higher in a relevant scientific discipline.
- 6+ years of UK regulatory experience, with a track record of managing major submissions and approvals via MHRA pathways.
- Experience handling post‑Brexit UK regulatory applications.
- Strong knowledge of clinical trial requirements and associated regulatory processes.
- Strategic thinking with strong commercial awareness and understanding of EU and UK medicines development.
- Excellent communication, leadership, and stakeholder management skills.
- Based in the UK and able to commute to West Berkshire on a hybrid basis.
Why Join?
- Play a key strategic role in bringing innovative medicines to patients in the UK and Ireland.
- Work within a collaborative, forward‑thinking organisation with a strong global footprint.
- Enjoy a competitive remuneration package and a broad range of benefits.
- Be part of a culture that values development, encourages progression, and supports wellbeing.
This role does not offer job sponsorship, so you must hold the full right to work in the UK with no restrictions. You must also be based within a commutable distance to the site.
Senior Manager Regulatory Affairs in Reading employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Regulatory Affairs in Reading
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who work in pharmaceuticals. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and Ireland regulatory processes. Be ready to discuss your experience with MHRA and HPRA, as well as any major submissions you've managed. Confidence is key!
✨Tip Number 3
Showcase your leadership skills! When discussing your past roles, highlight how you’ve mentored teams and driven projects forward. Employers love to see candidates who can inspire and lead others.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals to join our team and make a difference in regulatory affairs.
We think you need these skills to ace Senior Manager Regulatory Affairs in Reading
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Manager role. Highlight your relevant experience, especially in UK regulatory processes and leadership roles. 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 the perfect fit for this position. Share specific examples of your achievements in regulatory affairs and how you can contribute to our team at StudySmarter.
Showcase Your Leadership Skills: Since this role involves leading a team, make sure to highlight your leadership experience. Talk about how you've mentored others and driven successful projects in the past. We love seeing candidates who can inspire and develop their teams!
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 the role. Plus, it shows you’re keen on joining our awesome team!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on the latest UK regulatory guidelines and processes, especially those related to MHRA and HPRA. Being able to discuss recent changes or challenges in the regulatory landscape will show that you're not just knowledgeable but also proactive.
✨Showcase Your Leadership Skills
As a Senior Manager, you'll need to demonstrate your leadership capabilities. Prepare examples of how you've successfully led teams, mentored colleagues, or managed complex projects. Highlighting your ability to inspire and develop others will resonate well with interviewers.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or team dynamics. Think through potential scenarios you might face in this role and prepare structured responses that showcase your strategic thinking and problem-solving skills.
✨Engage with the Interviewers
Don't forget that interviews are a two-way street! Prepare thoughtful questions about the company's regulatory strategy and team dynamics. This not only shows your interest but also helps you gauge if the company culture aligns with your values.