Administrative Assistant - Regulatory Affairs

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of innovative & generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

We are looking for an Administrative Assistant to mainly support our Regulatory Affairs Department.

We are seeking a proactive and detail-oriented Regulatory Affairs Assistant to join our team. This role will provide essential administrative support to the Regulatory Affairs function, ensuring smooth day-to-day operations, accurate documentation management, and timely sharing of reports.

The ideal candidate will have prior experience in an administrative environment, and a strong ability to manage multiple priorities with accuracy and discretion.

How you’ll spend your day

• Understanding the work schedules and ways of working of the team members you will support
• Variations submission on the NCA portal, including uploading product information (SPC, PIL, and labeling), which is essential for PHV audits and inspections
• Managing the provision of organisational, travel and other logistical support to the Team members
• Organise and maintain regulatory files to ensure accurate and compliant record-keeping
• Support preparation of documentation for audits and inspections
• Support the maintenance of documentation control systems, ensuring timely approval and distribution of controlled documents
• Using our internal SAP system for managing requisitions and purchase orders
• Assist in the maintenance of compliant technical files in line with the applicable regulatory requirements
• Submit new MA submissions on the NCA portal
• Regulatory fee management, including payment processing and documentation, as well as coordination with accounting and shared services for month-end accruals and clawback reports
• POA management, including for hospital tenders
  
  

Your experience and qualifications

• Fluent English Level
• Exceptional organizational and time-management skills with the ability to manage multiple priorities and deadlines
• Previous administrative experience in a regulatory, compliance, or quality setting
• Familiarity with regulatory and quality documentation, submission processes, and file maintenance
• Ability to work in a fast-paced environment across multiple projects simultaneously. Reliable, proactive, and adaptable to changing priorities
• Clear, concise communication skills - both written and verbal
• Proactive thinking - you anticipate needs, solve problems before they happen, and take ownership
• Ability to work independently while being a collaborative team player
• Knowledge of SAP systems would be an advantage

Reports To

Regulatory Affairs Manager 

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