Associate Director, Global Regulatory Labeling Strategy

How You Will Contribute

• Independently lead cross-functional labeling teams, driving collaboration and alignment on global labeling strategy and content.
• Coordinate the labeling approval process through the Global Labeling Oversight Committee (GLOC), in partnership with the appropriate labeling and product leads.
• Prepare and align GLOC chairs, members, and their respective functions for labeling reviews and decisions.
• Author and manage new and revised TLPs, CCDSs, USPIs, EU SmPCs, and other labeling documents for assigned products.
• Develop and execute labeling implementation plans that incorporate new scientific, clinical, and safety data, as well as Health Authority feedback.
• Coordinate global labeling sub-functions to support timely end-to-end label development, Health Authority submissions, and labeling negotiations.
• Lead or support labeling negotiations with Health Authorities in collaboration with the Global Regulatory Lead.
• Interpret applicable laws, regulations, and guidance to ensure Takeda's labeling content and processes comply with regulatory requirements.
• Manage the alignment of local labeling with the CCDS, including the assessment of local exceptions and alignment deferrals.
• Support local affiliates in responding to Health Authority requests and addressing local labeling requirements.
• Identify and escalate labeling risks and issues to Global Labeling leadership and the Global Regulatory Lead, while recommending appropriate mitigation strategies.
• Build effective partnerships across Clinical, Safety, Medical Affairs, Commercial, Regulatory, and other functions to support labeling strategy and content.
• Conduct precedent research and analyze competitor labeling, Health Authority requests, regulatory guidance, and emerging labeling trends.
• Develop labeling strategies and language that align with the overall product strategy and support competitive and compliant product labeling.
• Represent Global Labeling on Global Regulatory Teams and in departmental or cross-functional initiatives.
• Partner with US Labeling Operations, EU Labeling Operations, Labeling Devices, and Labeling Compliance to ensure objectives and timelines are met.
• Support US, EU, and global Health Authority inspections by responding to labeling-related information requests.
• Oversee labeling activities performed by external vendors, ensuring timely delivery, seamless coordination, and adherence to quality standards.
• Contribute to the continuous improvement of labeling processes by identifying and implementing opportunities to improve agility, efficiency, and accuracy.

Minimum Requirements and Qualifications

• Bachelor's degree in a scientific discipline required.
• An advanced scientific degree, such as an MSc, PhD, or PharmD, is preferred.
• Eight or more years of pharmaceutical industry experience, including: Six years of labeling experience; or Five or more years of regulatory or related experience.
• Demonstrated experience creating, revising, or updating global product labeling, including CCDSs, USPIs, and EU SmPCs.
• Experience developing Target Labeling Profiles with limited supervision and guidance.
• Strong knowledge of US and EU product labeling requirements, regulations, and guidelines.
• Experience interpreting scientific, clinical, safety, and regulatory information for use in product labeling.
• Understanding of global regulatory requirements and regional labeling considerations.
• Knowledge of scientific principles and regulatory and quality systems relevant to drug development.
• Understanding of Health Authority audit and inspection processes.
• Strong project management skills, with the ability to independently manage priorities, timelines, and deliverables.
• Demonstrated ability to analyze complex regulatory issues, assess risk, and develop practical mitigation strategies.
• Excellent written, verbal, and presentation skills, with the ability to communicate complex regulatory information clearly and concisely.
• Demonstrated ability to lead multidisciplinary, cross-functional teams and build alignment among stakeholders with varied perspectives.
• Strong negotiation, stakeholder management, and conflict-resolution skills.
• Ability to work effectively in a global, matrixed environment and adapt to changing priorities.
• Strong attention to detail and a commitment to delivering accurate, complete, and high-quality labeling materials.
• Ability to promote an inclusive culture that encourages open dialogue, feedback, and diverse perspectives.