Regulatory Systems Specialist - My client a top 10 pharmaceutical company has a vacancy for a regulatory affairs systems specialist to support the activities of the their high performing regulatory team. This position requires a knowledge of regulatory systems and databases and a high level of IT literacy. Ideally you will have experience in a similar role in large pharma/biotech and have a can-do attitude and a friendly, approachable demeanour.

Basic qualifications:

• Excellent understanding and familiarity with databases and systems. IT background not essential.
• Good high-level understanding of Regulatory Affairs from an operational perspective. Understanding of regulatory registration process and registration tracking.
• Excellent organisational skills.
• Advanced knowledge of Microsoft Office application, especially Excel. Ability to use advanced Excel functionality to manipulate reports and produce metrics.
• Experience of systems analysis and data management with the ability to analyse data and report from databases.
• Clear and accurate editorial skills in ensuring that all data is presented in the most consistent, meaningful way.
• Bachelor Science Degree.

 Preferred qualifications:

• Technical knowledge of Lotus Notes.
• Knowledge of Consumer Healthcare registration processes.
• Familiarity with the range and types of non-prescription healthcare products, including over-the-counter (OTC) medicines, cosmetics and devices.
• Familiarity with systems validation and project quality methodologies (e.g. iQMS).
• Experience in managing projects.

Details

The Regulatory Systems team is responsible for management of the Global Regulatory Tracking database for the business. The registration information contained in the database is critical to the support of key regulatory processes and to enable the company to meet its legal and regulatory obligations including pharmacovigilance, GCP and GMP.

We are looking for a new team member who can use his/her database skills to help us to manage and improve our registration tracking system. We need someone proactive who will be able to take his/her own initiative to drive improvements. As this role involves interacting with senior management and with colleagues around the world, we are looking for someone who has experience in working with stakeholders from a broad range of cultures, seniorities and who has excellent verbal and written and presentation skills.

We have some exciting activities coming up, including replacement of the current system with a new solution, so we are looking for someone who enjoys and embraces change.

This role will be a key contact for registration information and support for a broad range of registration processes and will deputise for the Regulatory Systems Manager as required.

Key Responsibilities

Data Support

• Perform ad-hoc database queries and run reports.
• Design and validate key compliance reports.
• Ensure that data conflicts, errors and inconsistencies are rectified.
• Data optimisation, including product definitions, manufacturing codes and links to external documentation.
• Maintenance of all system generated memos.
• Recommend system or process change to address data quality issues.

 User Support

• Champion the importance of registration tracking within the organisation through regular communication with stakeholders.
• Provide leadership and support, as required by the Systems Manager for related initiatives including system upgrades and enhancements.
• Author and maintain process documentation and training materials.
• Deliver system training as required.
• Contribute to the ongoing definition of Business Requirements.
• Define and validate additional standard user reports.
• Liaise with Local Operating Company (LOC) staff located globally, to resolve technical or data related issues.

 
Systems Support

• Monitor system performance and operational effectiveness to identify and resolve issues.
• Identify and implement agreed system enhancements or upgrades and implement new functionality to support regulatory process and reporting needs.
• Partner with IT on implementation and change control activities.
• Contribute to the development of iQMS IT quality documentation to support user acceptance, including test scripts and reports.
• Provide systems support, including management of user access and roles, maintenance of standard memos and workflows.
• Leads Regulatory systems projects, as assigned.