Regulatory Affairs Senior Specialist

Overview

In this role you will shape regulatory strategies and manage UK submissions for oncology products, contributing to paediatric filings, new marketing authorisation applications and launches. You will oversee lifecycle maintenance of registered particulars and ensure compliant communication of MA changes across stakeholders. You’ll work with cross-functional teams and external regulators to drive timely approvals and ongoing compliance. This position offers flexible, hybrid working to balance business needs with personal requirements. Join a mission-driven company advancing science to deliver impactful medicines.

Pay / Benefits

• Flexible working
• Hybrid work model

Responsibilities

• Develop regulatory strategy and support filing activities for paediatric submissions, new MA applications and product launches
• Manage lifecycle maintenance of marketing authorisation items and associated documentation
• Liaise and negotiate with the Medicines and Healthcare products Regulatory Agency
• Implement and communicate MA changes to stakeholders
• Generate and maintain prescribing information, patient leaflets, and packaging components; manage artwork and regulatory compliance
• Maintain up-to-date knowledge of European and UK regulatory legislation to advise internally
• Advocate on regulatory issues and contribute to policy discussions internally and externally
• Represent Regulatory Affairs at cross-functional meetings, including product acquisitions and ad-hoc issues
• Utilise company compliance systems to meet regulatory expectations
• Collaborate actively within the UK regulatory team and with other stakeholders
• Maintain positive relationships with internal and external regulatory contacts

Key requirements

• BSc degree or higher in pharmacy or a life-science subject
• Solid regulatory affairs knowledge within the pharmaceutical industry
• Understanding of EU and UK regulatory procedures and legislation
• Experience with regulatory submissions and interaction with a regulatory authority is advantageous
• Excellent verbal and written communication and interpersonal skills
• Ability to work on own initiative and manage day-to-day regulatory activities for a portfolio
• Team-oriented work style with other stakeholders to achieve company objectives
• Strong multitasking and time-management abilities
• Genuine interest and knowledge of the regulatory environment in pharma
• Ability to identify and escalate compliance risks

• Excellent communication skills
• Strong teamwork and collaboration
• Proactive problem-solving and initiative
• Regulatory strategy development
• Regulatory submissions and submissions management
• Regulatory compliance and lifecycle management

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