Global Labeling Director: Strategy & Alliances (Oncology)

Merck & Co.; Basking Ridge (NJ); On-site; USD 193,000 - 290,000; Full time

Job summary

Daiichi Sankyo, Inc. is seeking a Director of Global Labeling to lead and coordinate labeling strategies for a major product under a global alliance.

The role oversees CCDS, US/EU labeling, and country-specific labeling reviews to ensure regulatory compliance and timely delivery across regions. The position leads Global Labeling Strategists, collaborates with Regulatory Affairs, Clinical, Medical, Safety, Legal, and Commercial teams, and guides labeling governance to meet business goals and

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
• Advanced degree (Master's, PharmD, or PhD) in a relevant scientific discipline preferred.
• 10+ years pharmaceutical industry experience.
• 4+ years direct regulatory affairs experience, including CCDS and US/EU labeling.
• Country labeling experience outside US/EU is a plus.
• Leadership in global regulatory labeling, preferably for oncology products.
• Experience with FDA, EMA, PMDA and international labeling requirements.
• Strong verbal and written communication with internal/external stakeholders.
• Experience in global alliance partnerships is a plus.

Responsibilities

• Lead global regulatory labeling strategies for assigned portfolio and serve as labeling strategy SME for GPTs.
• Manage preparation, review, and approval of labeling content for new submissions, variations, and updates for marketed products; oversee US/EU labeling.
• Support global labeling governance; coordinate with alliance partners to address regulatory labeling matters.
• Collaborate with cross-functional teams to meet labeling milestones and project objectives.
• Monitor changes in global labeling regulations and ensure compliance.

Skills

Leadership in labeling

Regulatory affairs

Communication skills

Education

Bachelor's in Life Sciences/Regulatory

Advanced degree preferred

Job description

Daiichi Sankyo, Inc. is seeking a Director of Global Labeling to lead and coordinate labeling strategies for a major product under a global alliance.

The role oversees CCDS, US/EU labeling, and country-specific labeling reviews to ensure regulatory compliance and timely delivery across regions. The position leads Global Labeling Strategists, collaborates with Regulatory Affairs, Clinical, Medical, Safety, Legal, and Commercial teams, and guides labeling governance to meet business goals and