Regulatory Affairs Associate

1 month ago

London, Greater London, United Kingdom Perrigouk Full time
Regulatory Affairs Associate

We are seeking a highly skilled Regulatory Affairs Associate to join our Central Regulatory Affairs team in London, Ghent, Paris, or Rotterdam. As a key member of our team, you will be responsible for ensuring the regulatory compliance of our medicinal products across European territories.

Key Responsibilities
  • Work on a diverse range of post-authorization regulatory projects to meet business needs and ensure regulatory compliance of our products with all relevant legislation.
  • Develop and implement regulatory strategies to maintain marketing authorizations across numerous territories.
  • Prepare and submit product license variations, renewals, PSUR submissions, and other post-authorization applications to meet business needs in accordance with current legislation.
  • Maintain oversight of assigned projects, escalate identified risks to compliance or supply, and take prompt action when urgent issues arise.
  • Produce clear written communications to convey understandable and appropriate messages to internal and external stakeholders.
  • Support all central regulatory lifecycle maintenance activities.
  • Assess the regulatory impact of administrative, quality, and safety-related change controls and complete related actions in accordance with procedures in place.
  • Maintain accurate and complete records by updating relevant trackers, product folders, and regulatory databases used by the Central RA team.
  • Support the development and training of regulatory best practice and procedural documents.
  • Report on task and project progress to line manager, other stakeholders, and via relevant regulatory tracking tools in accordance with best practice and procedures in place.
Requirements
  • Bachelor's or master's degree in a scientific discipline in a pharmaceutical, chemical, or biological field or other relevant fields.
  • 1-2 years of experience in a regulatory affairs environment, ideally within UK or EU OTC medicines including post-authorization activities.
  • Ability to work on several concurrent projects/products and adapt to changing priorities.
  • Competent user of MS Outlook, Teams, Word, and Excel.
  • Being thorough, focused, and with excellent attention to detail.
  • Excellent verbal and written communication in English.

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

We promote flexibility with the ability to work two days a week from home in many roles, allowing you to maintain a healthy work-life balance.

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