Senior Regulatory Affairs Associate – UK & Ireland

Cpl Life Sciences; Basingstoke; On-site; GBP 34,000 - 56,000; Full time

Job summary

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, based in the UK & Ireland.

The role covers regulatory submissions, lifecycle management, labelling and compliance across the UK & Ireland, with significant labelling experience essential.

Qualifications

• Bachelor’s degree or equivalent within a relevant scientific or life sciences discipline.
• Experience in pharmaceutical Regulatory Affairs is required.
• Strong labelling experience is essential.
• Experience supporting regulatory submissions and lifecycle activities.
• Understanding of UK regulatory requirements and processes.
• Strong organisational and time-management skills with ability to manage multiple activities.
• Excellent written and verbal communication skills.
• Proficient IT and regulatory systems experience.
• Experience interacting with external regulatory agencies.
• Experience across Marketing Authorisations, variations, renewals and product launches.
• Strong project management, analytical and problem-solving skills.

Responsibilities

• 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.

Skills

Regulatory affairs

Labelling

Submissions

Lifecycle management

UK regulations

Organisational skills

Communication

IT systems

Agency liaison

Project management

Analytical thinking

Problem solving

Education

Bachelor’s degree in life sciences

Job description

Senior Regulatory Affairs Associate – UK & Ireland

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.

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

• 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

• 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.
• Good IT and regulatory systems experience.
• 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 [e-mail]