Who we are
For more than a century, our organisation has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our organisation continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
This Early Talent Student Rotation Assignment will work within our Company’s Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regulatory Affairs Operations - Europe, Middle East and Africa (RAO-EMEA) department. We are a diverse, dynamic team who provide an opportunity to develop a career in regulatory operations and play a key role in ensuring patients have access to our products which positively impact human life.
It will entail working with one or all three of the Regulatory Submission Planning, Publishing, and Health Registration Management (HRM) teams.
The Regulatory Submissions Planning and Publishing team support the planning and project management of regulatory submission development, assembly, and release to the country subsidiary or direct to health authority. The HRM team support data entry into the HRM database, used to track the company’s registration information, which supports product release, compliance activities, and pharmacovigilance obligations.
Regulatory Submission Planning
- Planning, coordinating and reviewing regulatory submissions with release to Country Operations teams and/or submission to Health Authorities.
- Responsible for developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
- Participate in Submission Planning Management Team (SPMT) meetings.
- Drive the submission assembly and delivery process with the Global Submission Publishing team to ensure timely assembly, publishing and archival of assigned products/submissions as per the agreed timelines.
- Responsible for accessing and maintaining the regulatory systems and databases to fulfil daily functions.
Regulatory Submission Publishing
- Responsible for identifying and maintaining requirements supporting regulatory dossier assembly (aka publishing) and delivery to regulatory health authorities or to the country organization in the region.
- The publisher will support the maintenance of related processes in accordance with regional/country requirements, and also will support the central publishing team responsible for executing the assembly processes to generate regional/country compliant to regulatory requirements.
- The publisher will execute the assembly and delivery processes, in particular to meet critical submission targets. The RDP will be the regional expert for regulatory submission capabilities, including dossier structures and file formats, electronic submissions and transmission (e.g. agency gateways), dossier repositories and databases.
- Maintain the regional/country regulatory dossier assembly requirements (structure, organization, formats: paper and electronic, delivery methods, etc.)
Health Registration Management
- Assist in supporting regional procedures to ensure HRM data entry is compliant.
- Assist in the identification and resolution of data-entry- related errors within the specified region.
- Support, and at times lead, efforts surrounding HRM metrics within the region.
- Assist in the implementation of HRM data quality strategies in the region and support users in the execution of the strategy at the country level.
- Develop standard responses for common queries which can then be used as “mini refreshers” for the HRM Community of Practice meetings.
- You will be looking to complete a 12-month placement in your third or penultimate year of study, returning to your degree course at the end of the placement
- Technical specifications are flexible, but an affinity for and capability to learn Regulatory Information Management systems to execute operational tasks will be a significant asset
Qualities we look for
- Operates with a high level of integrity, transparency and accountability
- Comprehends and aligns with our organization’s core values
- Aligns and fosters a culture of diversity and inclusivity
- Demonstrates initiative, proactivity and academic curiosity
- Encourages and boosts their colleagues through teamwork
- Demonstrates clear and effective communication
- Ability to build relationships with various stake holders
- Demonstrates a desire to learn and improve their performance through feedback
- Demonstrates ability to prioritize multiple tasks and work under tight deadlines