Regulatory Affairs Executive

Get AI-powered advice on this job and more exclusive features.

We are seeking a highly motivated and detail-oriented RA Executive to join our consulting company. The successful candidate will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of clients' products across the UK and Europe, with a primary focus on the UK, covering human and veterinary medicines, medical devices, biocides, cosmetics, general products, and supplements.

Key Objectives

• Complete regulatory and technical work as required for various product categories, including human and veterinary medicines, medical devices, biocides, cosmetics, general products, and supplements.
• Communicate effectively with regulatory authorities and notified bodies.
• Contribute to process improvements within the Regulatory team.

• Independently prepare regulatory submissions for medicinal products, including but not limited to new license applications, variations, responses to questions, and renewals.
• Coordinate and review technical documentation.
• Support regulatory compliance for medical devices.
• Author sections of Module 3 of dossiers and Quality Overall Summaries.
• Provide technical support within the regulatory framework.
• Participate in regulatory team meetings, manage assigned tasks/projects, and provide regular updates.
• Use and update regulatory information systems to plan, prepare, track, and store submissions to regulatory agencies.
• Undertake any other duties reasonably associated with this position as assigned by the Board of Directors.

• 3 years of relevant experience in regulatory affairs, specifically within the UK and European regulations.
• Experience managing artwork generation, labeling, and updates to product information.
• Hands-on experience with MLA, MAA, CTD, Variations, Renewals, Labeling, MAH Applications.
• Familiarity with software packages and databases such as Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat, etc.
• Strong organizational and communication skills.
• Ability to prioritize and deliver high-quality work efficiently.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Business Development and Sales

Industries

• Pharmaceutical Manufacturing