Cpl Life Sciences
Senior Regulatory Affairs Associate – UK & Ireland
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Senior Regulatory Affairs Associate – UK & Ireland
Location: Basingstoke
Working Pattern: Hybrid, 3 days per week on-site
Contract: 12 months
Rate: Up to £28.89 per hour PAYE
Cpl Life Sciences is partnering with a Top 5 Global Pharmaceutical company to recruit a Senior Regulatory Affairs Associate for an initial 12-month contract.
The successful candidate will support regulatory activities across the UK and Ireland, managing both operational and technical regulatory responsibilities. This is a broad affiliate Regulatory Affairs position covering product registrations, lifecycle management, labelling, regulatory compliance and launch support.
Significant labelling experience is essential for this position.
Key Responsibilities
Regulatory Affairs & Lifecycle Management
- Support the execution of regulatory plans in line with local requirements and business objectives.
- Prepare and support new Marketing Authorisation applications and other regulatory submissions.
- Manage post-approval activities including variations, renewals and periodic reporting.
- Coordinate high-quality regulatory applications, ensuring submissions and approvals remain on schedule.
- Provide the local affiliate perspective to regional and global Regulatory Affairs teams.
- Coordinate responses to requests from regulatory authorities and internal stakeholders.
- Monitor regulatory changes, assess potential impact and communicate requirements across relevant teams.
- Provide regulatory input into product launches, brand teams and new product planning.
- Support interactions with relevant regulatory authorities.
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Labelling
- Take responsibility for local Product Information and labelling activities.
- Ensure product information complies with UK and local regulatory requirements.
- Coordinate the submission, approval and implementation of labelling changes within required timelines.
- Work in accordance with global labelling procedures while ensuring alignment with locally approved information.
- Maintain accurate and high-quality labelling documentation.
Regulatory Compliance
- Maintain accurate regulatory systems, trackers, licences and regulatory documentation.
- Ensure marketed products remain compliant with applicable local regulations and quality requirements.
- Maintain complete and up-to-date regulatory records and archives.
- Support internal audits, assessments, self-inspections and external inspections.
- Assist with the implementation of corrective and preventative actions where required.
- Work cross-functionally with Quality and other internal teams to maintain regulatory compliance.
Cross-Functional & Process Support
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- Provide Regulatory Affairs expertise to cross-functional teams.
- Support launch readiness and other regulatory initiatives.
- Build effective relationships with internal stakeholders, regulatory bodies and relevant external organisations.
- Provide regulatory guidance and training to internal teams where required.
- Identify opportunities to improve regulatory processes and ways of working.
Experience & Qualifications
Essential:
- Bachelor’s degree or equivalent within a relevant scientific or life sciences discipline.
- Previous pharmaceutical Regulatory Affairs experience.
- Strong labelling experience is essential.
- Experience supporting regulatory submissions and lifecycle activities.
- Understanding of UK regulatory requirements and processes.
- Strong organisational skills with the ability to manage multiple regulatory activities and deadlines.
- Excellent written and verbal communication skills.
- Strong cross-functional stakeholder management skills.
- Good IT and regulatory systems experience.
Desirable:
- Experience interacting with external regulatory agencies.
- Experience across Marketing Authorisations, variations, renewals and product launches.
- Strong project management, analytical and problem-solving skills.
For more information, please contact lucy.kirkaldy@cpl.com
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