Associate Director - Global Labeling Compliance AIN

In this vital role you will lead and oversees the implementation of labeling strategies, processes and systems.

This role involves collaborating with cross-functional teams, including Regulatory Affairs, Quality, Operations and Supply Chain, to ensure global labeling compliance, streamline operations, and uphold high-quality standards.

The Associate Director will act as a senior point of contact for global, regional and local teams, advising on strategic decisions and maintaining inspection readiness and will be the main point of contact for global labeling related compliance and audits.

Additionally, this individual will mentor team members, optimize vendor relationships, and drive continuous improvement within labeling processes and systems.

Strategic Leadership and Process & System Optimization:

• Lead the strategic development and execution of labeling processes, systems and compliance initiatives across regions.
• Ensure alignment of labeling operations with global regulatory requirements, maintaining high standards and facilitating readiness for inspections.
• Drive continuous process improvement, implementing standard methodologies and refining workflows to enhance labeling efficiency and compliance.

• Partner with Regional Regulatory Affairs, Local Amgen Affiliates, and Operations teams to plan, implement, and monitor labeling changes, providing expert guidance to ensure regulatory compliance.
• Act as a senior advisor on complex labeling issues, coordinating closely with key collaborators to address labeling requirements across global markets.

• Be responsible for relationships with labeling vendors, managing performance to meet established Service Level Agreements (SLAs) and addressing critical issues as needed.
• Lead project management efforts for multi-regional labeling changes, coordinating cross-functional resources to meet timelines and regulatory requirements.
• Manage and monitor translation and artwork vendors, ensuring that project achievements and quality standards are consistently achieved.

• Lead operational activities to support US, EU, and other regional labeling processes, including the management of templates, readability, linguistic reviews, and regulatory formatting.
• Provide oversight for document management, including labeling templates, Standard Operating Procedures (SOPs), and training materials.

Team Development and Mentorship:

• Mentor and train team members and other staff on end-to-end labeling processes, fostering professional growth and knowledge sharing within the team.
• Develop training programs to elevate the understanding and application of labeling standards among junior team members and global regulatory staff.

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree and 3 years of Pharmaceutical, Regulatory, or Quality Management experience OR
• Masters degree and 10 to 14 years of Pharmaceutical, Regulatory, or Quality Management experience OR
• Bachelors degree and 14 to 16 years of Pharmaceutical, Regulatory, or Quality Management experience OR
• Diploma and 18 to 20 years of Pharmaceutical, Regulatory, or Quality Management experience

Preferred Qualifications:

• Experience with Labeling Management Systems preferably Veeva Vault.
• Expertise in global regulatory labeling requirements, especially for pharmaceuticals, with experience in end-to-end labeling.
• Strong project management and vendor management capabilities.
• Proficient in document management tools, with an analytical attitude for anticipating and resolving issues.
• Excellent communication and negotiation skills, with a proven ability to foster relationships across diverse teams.
• Demonstrated experience in continuous improvement practices and cross-functional leadership.