Senior Regulatory Affairs Associate UK and IRELAND
| Company: | Hays Specialist Recruitment |
|---|---|
| Salary: | £27 to £30 an hour |
| Hours: | Full-time |
| Location: | Cambridge, CB20 7TV |
| Working pattern: | Hybrid - 3 days remote |
| Job type: | Contract |
| Posting date: | 18 Sept 2026 |
| Closing date: | 18 Oct 2026 |
Summary
Your new company
We are partnering with a world-leading biopharmaceutical organisation to recruit a Senior Associate Regulatory Affairs professional. This is an exciting opportunity to join a highly collaborative regulatory team supporting innovative therapies throughout their life cycle, from regulatory submissions and label management through to compliance and agency interactions.This role offers the chance to work across a diverse portfolio of products, contributing to regulatory strategy, supporting product development activities, and ensuring compliance with local regulatory requirements.
Your new role
As a Senior Associate Regulatory Affairs, you will play a key role in planning and executing regulatory activities for assigned products and programmes. Working closely with regional and global stakeholders, you will help ensure timely submissions, maintain regulatory compliance, and support the implementation of effective regulatory strategies.Key Responsibilities
- Support the development and execution of local regulatory strategies aligned with global objectives.
- Plan and manage marketing authorisation and life cycle management submissions.
- Ensure all regulatory submissions are completed accurately and within agreed timelines.
- Act as a key contact for regulatory authorities and support agency interactions.
- Provide regulatory guidance to internal cross-functional teams.
- Develop and maintain local product labelling in accordance with regulatory requirements and company standards.
- Review and approve promotional and non-promotional materials from a regulatory perspective.
- Monitor changes in the regulatory environment and communicate potential business impacts.
- Support regulatory compliance activities, including agency commitments and post-approval obligations.
- Collaborate with global and regional teams to support clinical study activities where required.
- Contribute to urgent safety communications and regulatory responses when needed.
What you'll need to succeed
- Proven understanding of regulatory affairs principles within the pharmaceutical, biotechnology, or healthcare industry.
- Experience preparing and managing regulatory submissions.
- Knowledge of marketing authorisation maintenance and life cycle management activities.
- Understanding of national regulatory requirements relating to medicinal products.
- Ability to interpret and communicate scientific and clinical information effectively.
- Experience working within regulated environments, following policies, procedures, and SOPs.
- Strong stakeholder management and cross-functional collaboration skills.
- Excellent organisational skills with the ability to manage multiple priorities.
What you'll get in return
Flexible working options available.
What you need to do now
If you're a Regulatory Affairs professional looking to develop your career within a global, science-driven organisation, we'd love to hear from you.
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