[Hiring] Associate Director, Global Regulatory Labeling Strategy @Takeda

Role Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As the Associate Director, Global Regulatory Labeling Strategy, you will be responsible for developing and implementing labeling strategies and content for multiple products across various stages of drug development.

• Lead cross-functional labeling teams, collaborating with global stakeholders.
• Ensure Takeda’s product labeling is scientifically accurate, strategically aligned, competitive, and compliant with global regulatory requirements.

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).
• 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 incorporating new scientific, clinical, and safety data.
• Coordinate global labeling sub-functions to support timely end-to-end label development and Health Authority submissions.
• Lead or support labeling negotiations with Health Authorities in collaboration with the Global Regulatory Lead.
• Interpret applicable laws, regulations, and guidance to ensure compliance with regulatory requirements.
• Manage the alignment of local labeling with the CCDS.
• Support local affiliates in responding to Health Authority requests.
• Identify and escalate labeling risks and issues to Global Labeling leadership.
• Build effective partnerships across Clinical, Safety, Medical Affairs, Commercial, Regulatory, and other functions.
• Conduct precedent research and analyze competitor labeling and emerging labeling trends.
• Develop labeling strategies and language that align with the overall product strategy.
• Represent Global Labeling on Global Regulatory Teams and in departmental initiatives.
• Partner with US and EU Labeling Operations to ensure objectives and timelines are met.
• Support US, EU, and global Health Authority inspections.
• Oversee labeling activities performed by external vendors.
• Contribute to the continuous improvement of labeling processes.

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced scientific degree 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.
• Experience developing Target Labeling Profiles with limited supervision.
• Strong knowledge of US and EU product labeling requirements.
• Experience interpreting scientific, clinical, safety, and regulatory information.
• Understanding of global regulatory requirements and regional labeling considerations.
• Knowledge of scientific principles and regulatory systems relevant to drug development.
• Understanding of Health Authority audit and inspection processes.
• Strong project management skills.
• Demonstrated ability to analyze complex regulatory issues.
• Excellent written, verbal, and presentation skills.
• Demonstrated ability to lead multidisciplinary, cross-functional teams.
• Strong negotiation, stakeholder management, and conflict-resolution skills.
• Ability to work effectively in a global, matrixed environment.
• Strong attention to detail and commitment to high-quality labeling materials.
• Ability to promote an inclusive culture.

Benefits

• Competitive salary range: $154,400.00 - $242,550.00.
• Equitable pay practices.
• Comprehensive benefits package.

Company Description

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are a patient-focused company that inspires and empowers you to grow through life-changing work.

• Certified as a Global Top Employer.
• Fosters an inclusive and collaborative workplace.
• Committed to delivering Better Health and a Brighter Future.