Assoc Dir Global Regulatory Affairs

Position Summary

• Leads preparation, review, and update of content for the development and maintenance of labeling and labeling components.
• Provides leadership, people management and tactical input on the planning and execution of labeling initiatives
• Formulates improvements to labeling policies, processes, quality, and system tools.
• Lead continuous improvement efforts of the end-to-end labeling process
• Develop and implement strategies to enhance global labeling awareness and tracking
• Demonstrate a high-level understanding of labeling content requirements, regulations and guidance in support of labeling strategies.
• Support inspection readiness activities related to all global labeling components
• May be assigned additional responsibilities as deemed necessary.
• Develop and maintain Target Product Profile, Company Core Data Sheet (CCDS) and local labels (US, EU, Canada)
• Evaluate and communicate risks associated with CCDS content updates and implementation strategies
• Understand and address key scientific, clinical, medical and payer needs, including commercial differentiation strategies
• Assess competitor labeling - understand precedents & opportunities for Health Authority (HA) discussions
• Support global HA interaction strategy to discuss key labeling elements
• During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies
• Develop clear communications for senior management and SOP approvers to streamline and facilitate final label negotiations and approval

Key job responsibility

• Ensures all labeling components (for new and existing product labels and labeling) are appropriately developed and maintained according to relevant laws and regulations – including the response to labeling request changes in an efficient manner to meet required timelines.
• Leads or contributes to cross functional teams: Labeling Committees, Labeling Teams, and provides direction and support and leadership to Product Review Council teams, Legal and other groups as needed.
• Present to Labeling Oversight Committee: Ensure Core Data Sheet accurately reflects current understanding of benefit/risk profile.
• Follows and formulates improvements to labeling policies, processes, quality, and system tools.
• Ensure policies and practices are maintained so that local labels are consistent with global labeling.
• Contribute, develop & implement solutions to build awareness and global strategic mindset
• Support all tracking, planning and storage activities related to labeling including any computer or manual system related activities
• Support inspection readiness activities related to all global labeling components
• Analyses and interprets new regulations and guidances as well as monitors and determines their impact on product labeling.
• Provides strategic advice on implementing new regulations as well as provides input for development of promotional messages as needed.

Knowledge, Skills, and Competencies

• Solid understanding of global labeling regulatory requirements and industry practice
• Solid understanding of medical concepts and terminology
• Strong written and oral communication skills
• Excellent computer skills including experience with Regulatory Information Management System (RIMS), EDMS, XML including SPL systems and MS Office: Word, Excel, PowerPoint, SharePoint and Outlook
• Ability to generate problem solving innovative solutions and motivate others to be innovative
• Ability to recognize and escalate issues
• Managing and Measuring Work
• Presentation Skills
• Interpersonal and Negotiation Skills

The ideal candidate should be action oriented, customer focused, able to manage workloads, set priorities, and have demonstrated the ability to build effective teams. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams and show strong business acumen.

Education and Related Experience Required

• PhD/MS/DVM/MD/BS in life sciences, scientific, or engineering field.
• 10+ years of relevant experience in pharmaceutical regulatory/labeling environment.
• Experience writing CCDS and USPI documents for new products.
• Demonstrated ability to work with and manage people in a global, dynamic environment to deliver value-added results.

Physical Demands and Work Environment

Travel (approximately 10%)

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take