Global Labeling Lead (Associate Director) | Regulatory Affairs
Industry Pharmaceuticals | Biotechnology | Regulatory Affairs | R&D Work Setting Remote / Hybrid | Global cross-functional R&D environment Job Summary A global pharmaceutical organization is seeking an Associate Director, Global Labeling Lead to drive labeling strategy and execution for multiple drug development programs across US and EU markets. This role leads cross-functional teams to develop, maintain, and implement product labeling content, ensuring compliance with global regulatory requirements while supporting product strategy and patient safety.
Key Responsibilities
- Lead global labeling strategy across assigned products (clinical to commercial stage).
- Author and manage key labeling documents (CCDS, USPI, EU SmPC, TLP).
- Coordinate cross-functional labeling teams and global stakeholders.
- Manage regulatory labeling submissions and health authority interactions.
- Ensure labeling compliance with US, EU, and global regulatory standards.
- Oversee implementation of labeling updates based on clinical and safety data.
- Support regulatory inspections and responses.
- Manage local labeling alignment and exceptions across markets.
- Drive labeling process improvements and operational efficiency.
Essential Requirements
- 8+ years pharmaceutical industry experience.
- 5–6+ years in regulatory labeling or related regulatory affairs.
- Strong experience with USPI and EU SmPC development.
- Knowledge of global regulatory labeling requirements (US, EU required).
- Experience working with cross-functional global teams.
- Ability to independently manage labeling strategy and documentation.
- Strong understanding of drug development and regulatory systems.
Preferred Requirements
- Advanced scientific degree (MSc, PhD, PharmD preferred).
- Experience interacting with health authorities (US/EU/global).
- Experience managing vendors or outsourced labeling activities.
- Strong project management and stakeholder leadership skills.
Ideal Candidate Profile Senior regulatory professional with deep labeling expertise, strong global regulatory knowledge, and experience leading cross-functional teams across complex pharmaceutical product portfolios.