Senior Global Labeling Strategy Lead

Planet Pharma; San Diego (CA); On-site; USD 150,000 - 195,000; Full time

Job summary

Planet Pharma is seeking an Associate Director, Labeling Strategy to develop and execute global regulatory labeling strategies across the product lifecycle. You will lead labeling for development and commercial products, ensuring USPI/EU SmPC compliance and alignment with strategic objectives.

You will partner with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal, and Quality to manage labeling, CCDS, SPL, and packaging considerations, and to prep

Qualifications

• 8+ years in pharmaceutical/biotech with direct labeling or regulatory experience.
• Strong knowledge of US and EU labeling requirements (USPI, EU SmPC).
• Experience leading global labeling programs and cross‑functional teams.

Responsibilities

• Lead Labeling multi-disciplinary team (LWG) to align on labeling strategy.
• Coordinate ELB reviews and labeling approvals across regions.
• Author and update CCDS, USPI, and global labeling content.
• Develop global labeling implementation plans for new data and agency responses.
• Oversee SPL process and collaboration with external vendors.
• Provide strategic direction to Local Labeling Leads for regulator requests.
• Ensure labeling content complies with regulatory requirements across US, EU and ROW.

Skills

Labeling strategy

Regulatory affairs

Project management

Cross-functional collaboration

Regulatory submissions

Attention to detail

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Planet Pharma is seeking an Associate Director, Labeling Strategy to develop and execute global regulatory labeling strategies across the product lifecycle. You will lead labeling for development and commercial products, ensuring USPI/EU SmPC compliance and alignment with strategic objectives.

You will partner with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal, and Quality to manage labeling, CCDS, SPL, and packaging considerations, and to prep