Director – Regulatory Affairs Labeling Execution

Director – Regulatory Affairs Labeling Execution

Requirements

• PharmD/PhD with 6+ years’ relevant experience
• MA/MS/MBA with 10+ years’ relevant experience
• BA/BS with 12+ years’ relevant experience
• 6+ years’ experience in prescription drug labeling
• Extensive experience leading development of end to end labeling process regulatory labeling or related strategies
• Significant experience in global management of drug labeling
• Experience leading global teams and projects in regulatory or related strategies
• Leadership experience with high complexity, cross-functional initiatives
• Experience driving inspection readiness and quality processes across the end-to-end labeling process
• Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally
• Knowledge of the biopharma industry
• In-depth knowledge in labeling operations compliance
• In-depth knowledge of systems, tools, metrics, and digital technologies to support global labeling
• Proven ability to influence up, down, and across the organization and externally
• Strong executive presence with demonstrated influence through leadership
• Exceptional interpersonal skills and understanding of team dynamics
• Strong communication and organizational skills
• Strong negotiation and conflict resolution skills
• Advanced coaching capabilities to mentor/develop staff
• Ability to travel when needed

Responsibilities

• Leads and oversees global labeling operations for core and regional labeling, translations and artwork
• Partners with cross-functional colleagues and vendors to execute core and regional labeling, translation and artwork deliverables
• Supports the design, implementation, and continuous improvement of standardized processes, Standard Operating Procedures (SOPs), and work instructions
• Agrees and implements outsourcing strategy applicable to core and regional labeling
• Ensures labeling documents meet the relevant regulatory requirements
• Ensures completion of applicable regulatory submissions
• Works with Global Labeling Leads (GLLs) and RA Liaisons to centralize artwork management
• Liaises with owners of systems used for artwork and translations
• Raises, informs, and resolves any issues that may impact operation activities
• Manages error process for labeling, translations and artwork
• Provides support for global HA audits/ inspections and legal requests relating to translations and artwork
• Ensures ongoing awareness of regulatory intelligence relating to labeling, translation and artwork activities

Preferred Qualifications

No preferred qualifications provided.