Job Summary

The Director, Global Labeling, Labeling Strategy, plays a crucial leadership role in Global Labeling by coordinating and managing labeling activities for a major product with multiple indications. This role oversees the development, maintenance, and implementation of labeling content for an existing product under a global alliance partnership. The position could also be responsible for new products under development. The position leads activities of Global Labeling Strategists (GLSs) and steps in as a GLS when needed. Acting as a subject matter expert, this role guides labeling strategy for Global Product Teams and its functions.

Key responsibilities include driving the creation and maintenance of the CCDS, US, and EU labeling, as well as overseeing the review of country-specific labeling deviations for Daiichi Sankyo products to ensure compliance with Health Authority regulations, internal procedures, and business goals. The position works closely with Labeling Operations & Compliance, cross-functional labeling working teams, alliance partners, and regulatory agencies to develop effective labeling strategies and maintain ongoing compliance.

Job Description

Responsibilities

• Labeling Leadership: Lead the development and execution of global regulatory labeling strategies for assigned portfolio, ensuring alignment with organizational priorities and alliance partner needs as appropriate.  Be the Labeling Strategy subject matter expert to the Global Product Team(s) (GPT). Serve as a role model for less experienced members of GRA labeling,                                                                                                                        
• Labeling Content Management: Manage the preparation, review, and approval of labeling content (including target labeling) for new product submissions, variations, and updates for marketed products, ensuring accuracy, consistency, and regulatory compliance. Oversee the management of company core data sheet(s), patient labeling, and product labeling for the US and EU, and support global implementation as needed. Support China and Japan through global labeling governance process as needed.
• 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.
• Alliance Partnership Coordination: Key point of contact for alliance partner on assigned product(s).  Ensure mutually agreed ways of working are aligned with DS processes and alliance agreements. Collaborate with alliance partners to address regulatory labeling matters, ensuring transparent communication and alignment on labeling strategies and deliverables.

Responsibilities Continued

• Compliance Monitoring: Track and interpret changes in global regulatory requirements related to product labeling, ensuring all activities remain current with applicable regulations, guidelines, internal and industry standards. Ensure compliance with internal processes for record keeping and tracking of labeling milestones. Collaborating with Global Labeling Operations and Compliance leads to produce high quality labeling documentation.
• 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

Education Requirements

• 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.

Experience Requirements

• 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
• Experience with country labeling a plus (outside the US/EU) preferred
• 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.
• Experience working within global alliance partnerships is a plus.