Global Core Labelling Strategy Director

Biopharma Careers; Washington; On-site; USD 112,000 - 236,000; Full time

Job summary

Mylan Inc. is seeking a Director of Core Labelling Strategy to lead and govern global product labelling across diverse products. You will develop, maintain, and implement CCDS and patient information in alignment with regulatory requirements.

The role interfaces with Global Regulatory, Medical, and PSRM, guiding strategies for labels across development and lifecycle management, including CCS and USPI submissions. Strong leadership and regulatory expertise are essential.

Qualifications

• Bachelor's degree in Science, Medicine or Pharmacy with regulatory experience.
• Experience in global labelling strategy and CCDS development.
• Knowledge of USPI and EU SmPC regulatory requirements.
• Ability to lead cross-functional labeling teams and communicate with senior management.

Responsibilities

• Manage global labelling process and CCDS development across the portfolio.
• Lead creation, review and approval of global and territorial labelling docs (CCDS, USPI, EU SmPCs).
• Drive labelling strategy in partnership with Global Regulatory and senior stakeholders.
• Lead Target Product Labelling development to support clinical strategy.
• Chair Product Labeling Teams and ensure regulatory alignment.

Skills

Regulatory leadership

Labelling strategy

Cross-functional leadership

Project management

Regulatory strategy

Education

Bachelor's degree in Science/Medicine/Pharmacy

Master's degree preferred

PharmD/PhD considered

Tools

CCDS system

USPI knowledge

Job description

Mylan Inc. is seeking a Director of Core Labelling Strategy to lead and govern global product labelling across diverse products. You will develop, maintain, and implement CCDS and patient information in alignment with regulatory requirements.

The role interfaces with Global Regulatory, Medical, and PSRM, guiding strategies for labels across development and lifecycle management, including CCS and USPI submissions. Strong leadership and regulatory expertise are essential.