Your Role:

As a Regulatory Labelling Specialist, you will be responsible for ensuring compliance with pharmaceutical regulations and laws. You will create and maintain global Reference Product Information and oversee the development and review of regulatory labels and product information.

Who You Are:

Minimum Requirements:

• Experience: 9-10 years in the pharmaceutical environment, including at least 5 years of labelling experience.
• Education: Medical, PharmD, or related discipline (minimum MSc or equivalent degree); higher degree preferred (e.g., PhD).

Maximum Requirements

• Lead professional employees and/or lower-level staff; support/service/operations managers to solve problems of limited to medium complexity. Adapt operational plans and priorities to address resource and short-term operational needs.
• Execute assigned tasks independently while adhering to agreed timelines and proactively communicating any potential risks. Follow up with cross-functional contributors on their deliverables in a timely manner. Maintain appropriate risk assessment and mitigation in cooperation with line management.
• Utilize advanced skills with all standard MS Office and business applications (Word, Excel, PowerPoint, MS Project, Outlook, Skype, SharePoint). Possess contributor-level experience with RIMS and EDMS RA applications.
• Demonstrate solid experience in Regulatory Affairs, including regulatory dossiers and procedures on a global scale. Understand the structure and processes of Regulatory Agencies and possess in-depth knowledge of registration procedures and lifecycle management strategies.
• Understand how business operates and make informed decisions while maintaining a strategic perspective. Have a thorough knowledge of EU regulatory requirements and labelling processes.