Senior Regulatory Affairs Manager – UK Affiliates
Location: West Berkshire, UK (Hybrid – 3 days onsite)
Package: Competitive salary + comprehensive benefits
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.
For more information or a confidential discussion, please contact: lucy.kirkaldy@cpl.com or leave a message at 0118 952 2797.
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.
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