Hiring: Director, Global Labeling Strategist Company: Daiichi Sankyo Location: Basking Ridge, NJ Job Posted Time: 2026-09-11 14:01:08 Target Skills & Keywords : Regulatory Compliance About the job Required Skills: •Labeling Negotiations: Strategize and plan for health authority negotiations, lead cross-functional labeling working teams through negotiations while ensuring alignment with senior management. •Cross-functional Collaboration: Serve as the regulatory labeling lead on cross-functional teams, working closely with Regulatory Affairs, Clinical, Medical Affairs, Safety, Legal, and Commercial to enable timely achievement of labeling milestones and project objectives. Build cross-functional and cross-regional relationships •Labeling Governance Support: Contribute subject matter expertise to labeling governance committees and facilitate feedback collection and resolution prior to committee review. Provide expert feedback on labeling strategy on all DS development products prior to governance. •Process Improvement: Identify and implement process enhancements to increase labeling efficiency, quality, and compliance, leveraging industry best practices and technological advancements. Contribute to/Lead process improvement initiatives as needed. •Actively support Global Labeling’s strategic objectives by fostering collaboration, sharing expertise and driving high standards of performance through feedback, aligning priorities, mentoring labeling strategists, facilitating effective communication between team members and leadership. 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 or more year pharmaceutical industry experience required •4 or more years of direct regulatory affairs experience, including CCDS and US/EU labeling experience required •Track record of leadership in global regulatory labeling , preferably for oncology products. •Proven experience with global regulatory agencies (e.g., FDA, EMA, PMDA) and international product labeling requirements •Strong verbal and written communication skills, with the ability to interact effectively with internal and external stakeholders. •Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!