Register Your Interest - Regional Regulatory Operations EU + EEMEA Student Placement

Register Your Interest - Regional Regulatory Operations EU + EEMEA Student Placement

The Associate Specialist will work within the our Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regulatory Affairs Operations International team based in Europe.

The Associate Specialist supports the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective across the Europe, Middle East, and Africa regions (EU & EEMEA).

As a member of cross-functional team and for the assigned products, her/she will support the team to manage all operational aspects for submission planning and execution of Original Marketing Application (OMA) and post-approval regulatory changes.

This position requires a keen interest of the regulatory landscape, its registration procedures and a willingness to understand the technical requirements for dossiers.

Primary Activities include but are not limited to:

• Support the planning and managing of regulatory operation projects from authorization through delivery to country regulatory affairs teams and/or Health Authorities.
• Supporting the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
• Participate in cross-functional forums and meetings
• With manager support, drive the submission assembly and delivery process with the Global and/or Regional 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.
• Assist in identifying opportunities to continually improve the efficiency of the submission processes and systems and participate in small-scale process improvement projects.
• Learn knowledge on the regional regulatory procedures on internal ​

Technical Requirements are flexible, but an affinity for and capability to learn Regulatory Information Management systems to execute operational tasks will be a significant asset. ​

Competences

• 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, particularly interpersonal, analytical, and customer service skills and oral and written communication skills.
• Demonstrates a desire to learn and improve their performance through feedback
• Demonstrates ability to prioritize multiple tasks and work under tight deadlines