Global Director, Core Labelling Strategy

Regulatory Toolkit; Washington (District of Columbia); On-site; USD 112,000 - 236,000; Full time

Job summary

Mylan Inc. in Washington, DC area seeks a Director Core Labeling Strategy to lead global labelling governance, development, and alignment across products.

The role requires strategic oversight of CCDS, USPI, and EU SmPCs, and effective supervision of cross-functional Product Labeling Teams to ensure regulatory compliance and product integrity. The successful candidate will drive Target Product Labelling development, coordinate with Global Regulatory, and influence lifecycle labeling strategies

Qualifications

• Bachelor's degree (or equivalent) in Science, Medicine or Pharmacy with 10 years of regulatory experience.
• Experience in global labelling strategy and development (CCDS, USPI, EU SmPCs).
• Experience leading labelling teams and cross-functional PLT/GLC governance.
• Experience developing first-submission labelling for major markets (US/EU).
• Strong communication and leadership across matrixed teams.

Responsibilities

• Accountable for the global labelling process and labelling development across the assigned portfolio.
• Leads preparation, review and approval of global labelling documentation (CCDS, Core Patient Information) and territorial labels to support regulatory filings.
• Drives labelling strategy in partnership with Global Regulatory and cross-functional teams.
• Leads development and maintenance of Target Product Labelling (TPL) to guide clinical strategy.
• Ensures close partnership with project leads and regulatory matrix to ensure effective labelling development.
• Chairs cross-functional Product Labeling Teams and collaborates with Medical, PSRM, and Safety teams.

Skills

Regulatory labeling

Leadership

Global labeling

USPI

EU SmPCs

CCDS

Target Product Labelling

Education

Bachelor's degree in Science, Medicine or Pharmacy

Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy

Job description

Mylan Inc. in Washington, DC area seeks a Director Core Labeling Strategy to lead global labelling governance, development, and alignment across products.

The role requires strategic oversight of CCDS, USPI, and EU SmPCs, and effective supervision of cross-functional Product Labeling Teams to ensure regulatory compliance and product integrity. The successful candidate will drive Target Product Labelling development, coordinate with Global Regulatory, and influence lifecycle labeling strategies