Senior Regulatory Affairs Associate Ireland

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.

• 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.

• 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.

• 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.

• 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.

• 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