Regulatory Affairs Officer – UK, EU

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Assist in managing the product life cycle.

• Oversee global applications for designated markets while adhering to local regulatory standards.

• Handle regulatory compliance initiatives within assigned markets.

• Process marketing authorization and post-authorization applications utilizing Centralised, Mutual Recognition, National, VMD-UK, and various global regulatory practices.

• Collaborate with regulatory authorities, representatives, affiliates, contract sites, laboratories, and internal teams.

• Address routine internal and external regulatory inquiries.

• Manage updates to artwork and approvals for labeling through ESKO AMS.

• Initiate change controls for regulatory modifications within the electronic quality management system.

• Implement and oversee the regulatory information management system.

• Assist in drafting, reviewing, and authorizing regulatory Standard Operating Procedures (SOPs).

• Ensure adherence to company SOPs, global regulations, and industry guidelines.

• Keep current with EU regulations, local compliance requirements, and VICH guidelines.

• Request Export Certificates, Certificates of Pharmaceutical Product (CPPs), samples, and Certificates of Analysis.

• Manage payment invoices related to applications.

• Update NOAH/AMTRA Compendium Datasheets using an online editor.

• Provide regulatory guidance for Product Development projects, including regulatory strategy and applications.

• Navigate electronic submission platforms such as the Union Product Database and IRIS.

• Upload regulatory submission documents following local protocols.

• Evaluate regulatory intelligence and discern its effects on processes and projects.

• Conduct gap analyses of technical documentation and identify potential challenges.

• Support various projects and other tasks as needed.

⛳️ Requirements

• A degree in Immunology, Biochemical Engineering, Biotechnology, or a related discipline is mandatory.

• Experience in vaccine development or manufacturing is preferred.

• Background in the animal health sector is advantageous, though training will be provided.

• Proficiency in electronic data management systems is essential.

• Strong organizational skills with the capability to work effectively both in a multi-disciplinary team and independently.

• Commitment to producing high-quality work with meticulous attention to detail.

• Excellent communication skills in both written and spoken English.

🏝️ Benefits

• Competitive salary package.

• Opportunities for professional growth and development.

• Supportive and collaborative work environment.

• Comprehensive health and wellness benefits.