Regulatory Operations Officer in Egham

The Regulatory Operations Officer will drive regulatory submission creation and management for UK, EU and Rest of the World markets. If you are keen to join a patient centric, high-growth company, then read on and apply today!

What You Will Do

• Work closely with regulatory strategy team to prepare applications for submission in EU, CH, UK, FSA, MENA, LATAM and APAC territories.
• Compile, publish, validate and dispatch regulatory dossiers (eCTD, NeeS, paper submissions) in line with regional/local requirements.
• Resolve technical validation issues with Competent Authorities.
• Use internal electronic systems for planning, preparing, tracking and storing submissions to Competent Authorities.
• Perform technical quality checks on submission output to ensure compliance with Competent Authority requirements.
• Participate in Regulatory Information Management System Project to enhance internal system.
• Collaborate with IT to troubleshoot and streamline publishing processes.
• Provide troubleshooting support for eCTD compilation and validation issues.
• Archive agency correspondence in a timely manner.
• Ensure archived submissions and records are compliant with internal quality standards and inspection-ready.
• Ensure all approved SmPC and PIL are uploaded to public portals where required.
• Share new and emerging regulatory publishing requirements with key stakeholders and make every effort to keep up to date with current requirements and responsibilities of the Marketing Authorisation holder.
• Ensure timely submission of variations, renewals, new marketing authorisation applications and responses to health authority questions.
• Maintain and update submission trackers, publishing tools and regulatory information management systems (RIM).
• Partner with Regulatory Affairs Managers, CMC, Clinical and Labelling colleagues to ensure documents are submission-ready.
• Lead or participate in process improvement initiatives including, system optimisation and SOP creation or update.
• Contribute to process improvements, SOP updates and training materials related to submissions publishing.

What We Do

Essential Pharma is a global pharmaceutical company working to make a difference for patients in niche populations. Everything at Essential Pharma is driven by the fact that every patient matters. We are focussed on developing and delivering medicines for patients in small, underserved or rare disease populations. Our team of 70+ people has an entrepreneurial spirit, challenging convention and working creatively to deliver results. Our headquarters are in Surrey, UK, and we have offices in Malta, France, Spain and Switzerland. We are an international business, with a growing product portfolio that reaches patients in approximately 70 countries. We cover multiple therapy areas with a particular focus on rare disease, CNS, ophthalmology and gastroenterology. Our first development-stage asset is an anti‑GD2 antibody for the treatment of high‑risk neuroblastoma. We have a proven track record of acquiring, investing in and commercialising treatments.

What You Will Bring

• Degree in Pharmacy, Chemistry, Pharmaceutical or life science.
• Experienced in submission creation and management using Mono eCTD, EXTEDO or similar eCTD publishing software.
• Previous regulatory publishing experience of preparing submissions for EU, CH, UK, FSA, MENA, LATAM and APAC territories.
• Hands‑on experience of submitting Type 1A, Type 1B, Type II variations for products approved via mutual recognition (MRP) and decentralised (DCP) procedures in the EU and NeES submissions in rest of the world markets.
• Competent in using Microsoft Word, PowerPoint, Excel and Regulatory Information Management Systems.

Core Competencies

• Demonstrate a Growth mindset and willingness to learn.
• Adapt to situations of high‑speed change.
• Solve problems and work through complex publishing requirements.
• 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.
• Good attention to detail in publishing.
• Working knowledge of dossier publishing requirements.
• Strong interpersonal skills and understanding of team dynamics.
• Excellent written and verbal communication skills in English language.

What We Offer

• We understand that productivity requires balance, so we offer office‑based contracts and allow flexibility on locations of work when required and appropriate.
• £150 towards your home office.
• Pension – you contribute 5% and we offer 5%.
• Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
• Enhanced family leave.
• 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.