Global Labeling Director: Strategy & Alliance Leader

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Daiichi Sankyo is seeking a Director, Global Labeling Strategist to lead global regulatory labeling strategies for a major product and potential future products under a global alliance. The role guides labeling content development, maintains CCDS and country labeling, and collaborates with alliance partners and regulatory agencies to ensure compliance and timely milestones.

The position requires 10+ years in pharma with 4+ years in regulatory affairs, including CCDS and US/EU labeling, and a

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field required.
• Advanced degree (Master’s, PharmD, or PhD) in a relevant scientific discipline preferred.
• 10+ years of pharmaceutical industry experience; 4+ years in regulatory affairs incl. CCDS and US/EU labeling.

Responsibilities

• Lead global regulatory labeling strategies for assigned portfolio and act as Labeling Strategy SME for GPTs.
• Oversee preparation, review, and approval of labeling content for new products and updates for US/EU markets.
• Coordinate alliance partner activities and ensure regulatory labeling compliance across geographies.
• Drive labeling governance, changes, and negotiations with health authorities and cross-functional teams.

Skills

Leadership

Regulatory strategy

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field

Advanced degree (Master’s, PharmD, or PhD) preferred

Job description

Daiichi Sankyo is seeking a Director, Global Labeling Strategist to lead global regulatory labeling strategies for a major product and potential future products under a global alliance. The role guides labeling content development, maintains CCDS and country labeling, and collaborates with alliance partners and regulatory agencies to ensure compliance and timely milestones.

The position requires 10+ years in pharma with 4+ years in regulatory affairs, including CCDS and US/EU labeling, and a