Regulatory Affairs Executive, Systems and Operations

Competitive Salary & Company Benefits Ideally located close to Petersfield or Leicester

Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day)

Are you looking to work for a rapidly growing UK Pharmaceutical company, who are passionate about improving patients' lives across the world?

Aspire Pharma is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets which are often underserved. The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.

Do you want to be part of the journey?

If so, here is your chance!

The Regulatory Affairs Executive, Systems and Operations is responsible for the effective management, maintenance, and optimisation of all regulatory information systems and operational processes within the organisation. This role plays a critical part in ensuring the accuracy, integrity, and accessibility of regulatory data, streamlining submissions, and enhancing overall regulatory compliance efficiency.

The executive will act as a key liaison between regulatory affairs, IT, and other departments to implement, troubleshoot, and improve the digital infrastructure supporting regulatory activities.

As a Regulatory Affairs Executive - Systems and Operations, you will be responsible for:

• Administer, maintain, and support regulatory information management systems (e.g. electronic document management systems (EDMS), regulatory information management (RIM) systems, submission publishing tools, tracking databases).

• Ensure the integrity, accuracy, and completeness of regulatory data within all systems.

• Manage user access, permissions, and training for regulatory systems.

• Monitor system performance, identify issues, and collaborate with IT and vendors for resolution.

• Stay abreast of new technologies and system enhancements relevant to regulatory affairs.

• Develop, implement, and maintain standardised regulatory operational procedures and workflows.

• Support the compilation, publishing, and submission of regulatory dossiers (e.g. eCTD) according to agency requirements (e.g. MHRA).

• Manage and track regulatory commitments, deadlines, and submissions to ensure timely delivery.

• Identify opportunities for process improvements and automation within regulatory operations to increase efficiency and reduce risk.

• Develop and maintain regulatory submission calendars and tracking tools.

• Facilitate regulatory intelligence gathering and dissemination within the organisation.

• Oversee the quality and consistency of regulatory data entry.

• Generate regular reports on submission status, regulatory commitments, and system metrics.

• Support the creation of dashboards and analytics to provide insights into regulatory performance.

• Ensure data archiving and retrieval processes comply with regulatory requirements.

• Ensure regulatory systems and processes comply with applicable regulations, guidelines (e.g. GxP, data integrity principles), and internal SOPs.

• Participate in internal and external audits related to regulatory systems and data.

• Support the development and maintenance of regulatory SOPs and work instructions.

• Implement and monitor change control procedures for regulatory systems and processes.

• Act as a subject matter expert and provide training and support to regulatory affairs staff and other departments on regulatory systems and processes.

• Liaise with IT, Quality Assurance, Research & Development, and other relevant departments to ensure seamless integration of regulatory activities.

• Collaborate with external vendors and consultants for system implementation and support

• Bachelor's degree in a scientific, technical, or related field (e.g. Life Sciences, Computer Science, Regulatory Affairs)

• Minimum of 2 years of experience in regulatory operations, regulatory systems management, or a similar role within the pharmaceutical, biotechnology, medical device, or other regulated industry.

• Proven experience with electronic regulatory submission formats (e.g. eCTD) and publishing tools.

• Hands on experience with regulatory information management (RIM) systems (e.g., Veeva RIM, Aris Global, Master Control, Lorenz docu Bridge).

• Experience with document management systems (e.g. SharePoint, Documentum, Open Text).

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

• Strong understanding of regulatory submission requirements and life cycles.

• Familiarity with regulatory agency portals and submission gateways.

• Knowledge of data integrity…