Global Labeling Strategy Director — Lead Regulatory Excellence

Initial Therapeutics, Inc.; Basking Ridge (NJ); On-site; USD 193,000 - 290,000; Full time

Job summary

Daiichi Sankyo, Inc. is seeking a Director, Global Labeling to lead regulatory labeling strategies for a major product across US/EU and alliance partners. You will supervise labeling content, coordinate with GPTs, and guide cross-functional teams to meet regulatory milestones.

This senior role requires a track record in global labeling, FDA/EMA experience, and strong leadership. You will mentor labeling strategists, drive governance processes, and ensure compliant, high-quality labeling

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
• Advanced degree (Master’s, PharmD, or PhD) preferred.
• 10+ years in the pharmaceutical industry.
• 4+ years of direct regulatory affairs with CCDS and US/EU labeling.
• Experience with global regulatory agencies (FDA, EMA, PMDA) and international labeling requirements.
• Experience with global alliance partnerships is a plus.

Responsibilities

• Lead development and execution of global regulatory labeling strategies for the assigned portfolio and act as the labeling strategy SME to the GPT.
• Oversee preparation, review, and approval of labeling content for submissions, variations, and updates for marketed products; manage core data sheets, patient labeling, and product labeling for US and EU; support global implementation.
• Strategize and plan health authority negotiations, lead cross-functional labeling teams to achieve milestones.
• Serve as the regulatory labeling lead on cross-functional teams with Regulatory Affairs, Clinical, Medical Affairs, Safety, Legal, and Commercial.
• Provide SME feedback to labeling governance committees and guide labeling strategy for DS development products prior to governance.
• Coordinate with alliance partner on labeling matters to ensure alignment with DS processes and alliance agreements.

Education

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

Job description

Daiichi Sankyo, Inc. is seeking a Director, Global Labeling to lead regulatory labeling strategies for a major product across US/EU and alliance partners. You will supervise labeling content, coordinate with GPTs, and guide cross-functional teams to meet regulatory milestones.

This senior role requires a track record in global labeling, FDA/EMA experience, and strong leadership. You will mentor labeling strategists, drive governance processes, and ensure compliant, high-quality labeling