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Theramex Logo Theramex · Pharmacy

Senior Product Specialist, Regulatory Affairs

United Kingdom, London · Job Posted April 16, 2026
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Job Description

The Senior Regulatory Affairs Product Specialist serves as a key regulatory partner to the business, providing strategic guidance and operational support across designated products and markets. The role ensures that regulatory objectives are fully aligned with business needs, drives compliant and efficient lifecycle management activities, and contributes to the successful execution of regulatory strategies across the product portfolio.

Job Responsibility

  • Preparation and submission of required regulatory packages for designated products/countries
  • Authoring/updating of key regulatory documentation including CTD components and Product Information
  • Development and implementation of regulatory strategy for required changes
  • Act as the contact within the business for regulatory advice and support related to designated products
  • Provide support and regulatory advice to key internal stakeholders
  • Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance
  • Communication with external stakeholders, including regulatory agencies, CMO’s and third party service providers
  • Creation and maintenance of Regulatory Information Management systems and databases records and entries
  • Support of creation and maintenance of SOPs, working instructions describing regulatory and labelling processes and best practices to ensure compliance

Requirements

  • Extensive experience with practical European Regulatory Affairs
  • Good understanding of MA lifecycle activities within DCP, MRP and National procedures (Post-authorisation variations, submission strategies, renewals, PSURs/PSUSAs)
  • Knowledge of CTD/eCTD documentation structure and lifecycle management
  • Knowledge of European regulations and related guidance documents for Regulatory submissions, Product Information authoring, CMC documentation, CTD and eCTD authoring
  • Able to perform other Regulatory Affairs activities with team support (e.g., PASS, PAMs, Centralised Procedure submissions)
  • Able to perform accompanying activities such as artwork reviews/approvals and Prescribing Information preparation
  • Good interpersonal skills and effective problem-solving capabilities
  • Proactive, adaptable and comfortable working across multiple projects while maintaining high standards
  • High attention to detail with excellent organisational and time-management skills
  • Excellent written and verbal communication skills in English
  • Desirable degree in Pharmacy, Biology, Chemistry or a related discipline
  • Desirable experience working with distributor markets via third-party contractors
  • Desirable experience in planning and project management

Nice to have

  • Desirable degree in Pharmacy, Biology, Chemistry or a related discipline
  • Desirable experience working with distributor markets via third-party contractors
  • Desirable experience in planning and project management

What we offer

  • 25 days holiday + 8 bank holidays
  • Private Health Insurance for employee and family members
  • Pension contribution: 10% company + 5% employee (auto-enrolled from day one)
  • Hybrid Working
  • Cycle to Work Scheme
  • Engaging employee experience to come together as a community: in-office events, shared learning and much more
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