Regulatory Information Officer

The Regulatory Information Officer is responsible for acting as the regulatory data steward for Essential Pharma Group’s licence portfolio across the UK, EU, Switzerland and Rest of World markets. They will make sure the licence and product data held in our Regulatory Information Management (RIM) system, and submitted to health authority databases such as EMA xEVMPD, SPOR and the PLM portal, is accurate, complete and ready for inspection at all times. If you are keen to join a patient centric, high-growth company, then read on and apply today!

Qualifications

• Degree in a life science, information management or related discipline, or equivalent practical experience in a regulated environment

Experience

• Experience using or supporting RIM, electronic document management or similar database systems (for example Veeva Vault)
• Knowledge of EU regulatory data standards and databases, such as xEVMPD (Article 57), SPOR and IDMP, is desirable
• Experience in document, records or data management within a regulated (GxP) environment, ideally pharmaceutical regulatory affairs
• Familiarity with regulatory procedures and document types, such as marketing authorisations, variations, renewals, SmPCs and PILs, is desirable
• Advanced user of Microsoft Excel, Word, SharePoint and Teams

Core Competencies

• Demonstrate a Growth mindset and willingness to learn
• Adapt to situations of high-speed change
• Solve problems and bring structure to complex information
• Demonstrate integrity and high ethical standards
• Demonstrates a willingness to achieve goals together and respect the view of others
• Results orientated and accountable for actions
• Excellent attention to detail and accuracy in data and document handling
• Organised and methodical, with the ability to manage multiple priorities and deadlines
• Strong interpersonal skills and understanding of team dynamics
• Excellent written and verbal communication skills in English language

Regulatory data stewardship (core, continuing responsibilities)

• Own the master regulatory data in the RIM system for all EPG licences, including product, licence, registration, manufacturer, contact and submission data, so that it is accurate, complete and current at all times.
• Process the data changes arising from health authority approvals and lifecycle events (variations, renewals, safety and labelling updates, licence transfers, manufacturing site changes, QPPV and contact changes, and cancellations) within defined timelines.
• Maintain the product data held in EMA and other health authority databases through the RIM system integrations, including xEVMPD (Article 57), SPOR (PMS, OMS and RMS) and the PLM portal, monitoring transmissions and resolving acknowledgement errors and rejections.
• Prepare and verify the product data needed for electronic application forms and lifecycle submissions, so that variations are not delayed or rejected because of data errors.
• Take over product database maintenance currently performed by external vendors on EPG’s behalf, and act as the regulatory data contact for Pharmacovigilance, Quality, Supply Chain and Commercial colleagues.
• Load and verify licence data for acquired and newly registered products, so that new products are integrated into RIM and the health authority databases within agreed timelines.
• Perform routine data quality checks and reconciliations across RIM, health authority databases, regulatory trackers and related records such as artwork and licence information, tracking data quality metrics and escalating discrepancies for resolution.
• Maintain data governance documentation, including data standards, controlled vocabularies, audit trails and work instructions, to support inspection readiness, including pharmacovigilance inspections covering Article 57 compliance.

Regulatory records and lifecycle support

• Manage the regulatory filing structure for health authority correspondence, approval letters, certificates and submission records, ensuring documents are archived promptly, named consistently and retrievable for audits and inspections.
• Ensure all approved SmPCs and PILs are uploaded to public portals and internal repositories where required, with current approved versions clearly identified.
• Support lifecycle activities (variations, renewals, new applications, licence transfers and cancellations) by organising supporting documentation, tracking timelines and following up actions with colleagues and partners.
• Maintain regulatory reference information, including health authority contacts, fees, procedural requirements and document templates.
• Coordinate document collection and version control with Regulatory Affairs Managers, CMC, Clinical, Labelling and Quality colleagues, and with external partners and distributors.
• Produce regular status reports and metrics from regulatory systems to support planning and management oversight.
• Contribute to process improvement, SOP and work instruction updates, and training materials relating to regulatory records, data management and systems.

RIM implementation (initial phase only)

• During the RIM implementation, support data cleansing, data loading and migration verification, and user acceptance testing, working alongside the Regulatory Systems lead, then take ownership of the data and its maintenance once the system is live.

What We Offer

• Competitive salary
• We understand that productivity requires balance, so we offer office-based contracts and allow flexibility on locations of work when required and appropriate. This can be different for each department so please have that conversation at interview
• Healthcare
• Pension – you contribute 5% and we offer 5%
• Life Insurance – lump sum (tax free) death benefit of 4 x basic salary
• Enhanced family leave
• Enhanced sick pay
• 25 days annual leave
• Discretionary annual performance bonus

What To Expect

• At Essential Pharma, every colleague matters: we want every member of the team to thrive and grow during their time with us
• Right from the interview stage, we encourage candidates to ask us questions, voice opinions and be curious
• This is a dynamic, fast-paced working environment. We expect individuals to be responsible and accountable, while understanding the importance of collaborating with colleagues to fuel success
• We pride ourselves on our inclusive culture, based on the belief that everyone brings unique strengths and perspectives
• We have an unwavering dedication to employee growth and development