Senior Regulatory Affairs Specialist

Senior Regulatory Executive - This role can be based from our offices in London, Barcelona or Belfast

Managing CMC regulatory activities, ensuring product quality and maintaining global regulatory compliance throughout the product lifecycle.

The Senior Regulatory Executive is responsible for managing regulatory activities for pharmaceutical and biological products, covering both initial marketing authorisation submissions and post-approval lifecycle management.

The role involves developing regulatory strategies, preparing and reviewing CMC documentation, assessing manufacturing and quality changes, and ensuring compliance with global regulatory requirements.

Working closely with Manufacturing, Quality Control, Quality Assurance, Supply Chain and Regulatory Affairs, the role supports successful regulatory submissions and ongoing product compliance, particularly for vaccines and biological products.

Key responsibilities

Regulatory strategy and submissions

• Develop strategies for initial and post-approval CMC activities, including Marketing Authorisation Applications (MAAs), Biologics License Applications (BLAs), variations, renewals, market expansions and annual reports.
• Support the preparation, review and maintenance of global regulatory submissions.
• Contribute to CMC sections of initial registration dossiers and post-approval submissions.
• Determine regulatory pathways and submission requirements.
• Ensure submissions comply with applicable regional and international regulatory guidelines.

Change control and regulatory assessments

• Evaluate manufacturing and quality control changes.
• Assess regulatory impact and determine appropriate variation classifications.
• Identify requirements for validation, stability and comparability data.
• Ensure proposed changes remain aligned with registered product information and regulatory commitments.

Technical documentation review

• Review process validation, stability and analytical method validation reports.
• Assess comparability studies and supporting scientific data.
• Ensure technical documentation meets regulatory and quality requirements.

Cross-functional collaboration

• Coordinate submission activities with Manufacturing, QC, QA, Supply Chain and Regulatory teams.
• Ensure timely preparation and review of technical documentation.
• Manage communication with global and local regulatory stakeholders.

Regulatory writing and project management

• Author and review CMC sections of MAAs, BLAs, regulatory dossiers and post-approval variations.
• Prepare and coordinate responses to health authority questions.
• Manage regulatory projects and global submissions within Regulatory Information Management (RIM) systems.
• Monitor submission timelines, regulatory commitments and deliverables.

Risk management

• Identify, assess and escalate regulatory risks.
• Develop mitigation strategies to address compliance issues and potential submission delays.

Technical knowledge and expertise

The successful candidate should have a strong understanding of:

• CMC regulatory requirements and product lifecycle management.
• MAA and BLA submission requirements and processes.
• Pharmaceutical manufacturing and quality systems.
• Vaccine and biological manufacturing processes.
• Stability studies and shelf-life requirements.
• Process qualification and validation.
• Analytical method validation.
• Comparability studies.
• GMP, change control and CAPA.
• CTD documentation and global regulatory requirements.

Experience and qualifications

• Experience in pharmaceutical Regulatory Affairs, particularly CMC, technical or quality-related activities.
• Experience authoring CMC sections of regulatory dossiers, including MAAs, BLAs and post-approval variations.
• Experience supporting initial marketing authorisation submissions and responding to health authority questions.
• Background in pharmaceutical manufacturing, Quality Assurance, Quality Control or Validation.
• Experience preparing and reviewing technical and regulatory documentation.
• Familiarity with biological processes and vaccine manufacturing.
• Strong understanding of qualification and validation principles.

Languages

• Fluent written and spoken English.

Key personal attributes

• Excellent attention to detail and analytical skills.
• Strong problem-solving and risk management capabilities.
• Effective organisational and project management skills.
• Excellent communication and stakeholder management.
• Ability to collaborate across multidisciplinary teams.