Director, Global Regulatory Labeling Strategy
Job Level: Senior
Travel: Minimal (if any)
Location: Remote
Company: Takeda
About Takeda:
For 240 years, Takeda has been transforming scientific discoveries into breakthrough medicines that impact millions of lives. As a global leader in R&D innovation, Takeda welcomes diversity of thought and fosters collaboration across teams to advance transformative therapies for patients worldwide.
About the Role:
As the Director, Global Regulatory Labeling Strategy, you will lead the development and implementation of global labeling content and strategies across multiple products at various stages of drug development. You will oversee critical regulatory documents such as TLP, CCDS, USPI, and EU SmPC, ensuring regulatory compliance and cross-functional alignment.
Responsibilities:
Management of Labeling Cross-Functional Teams:
Lead cross-functional teams, fostering collaboration and driving alignment on labeling strategy and content.
Coordinate labeling approvals through the Global Labeling Oversight Committee (GLOC).
Labeling Documents Authoring, Submission, and Labeling Negotiations:
Independently author and manage TLPs, CCDS, USPIs, and EU SmPCs with cross-functional input.
Develop and execute labeling implementation plans ensuring compliance and minimizing risks.
Lead global labeling sub-functions to ensure timely Health Authority submissions and negotiations.
Management of Local Exceptions and LOC Interactions:
Align local labeling with CCDS standards, assessing exceptions and deferrals.
Support local affiliates in responding to health authority labeling requests.
Escalation Process and Stakeholder Management:
Escalate significant issues appropriately, proposing risk mitigation strategies.
Build strong, strategic relationships across clinical, safety, medical affairs, and commercial teams.
Precedent Search and Labeling Trends:
Conduct precedent searches, competitor analyses, and evaluate labeling trends to optimize product labeling strategies.
Working Within Labeling Team and GRA:
Represent Global Labeling at Global Regulatory Team meetings.
Collaborate with US and EU Labeling Operations and participate in cross-functional initiatives and Health Authority inspections.
People Management:
Supervise and mentor Global Labeling Leads (GLLs), providing guidance, performance management, and professional development support.
Vendor Management:
Oversee activities performed by external vendors related to assigned product labeling.
Continuous Improvement:
Identify and implement process optimizations to enhance labeling agility, efficiency, and accuracy.
Minimum Requirements/Qualifications:
Bachelor’s degree in Science (BSc); advanced degrees (MSc, PhD, or PharmD) preferred.
10+ years of pharmaceutical industry experience, including 8+ years in labeling or a combination of regulatory and labeling experience.
Required Skills and Competencies:
Strategic Thinking:
Ability to develop clear and executable regulatory strategies aligned with business priorities.
Communication:
Strong verbal and written communication skills, able to effectively collaborate across global, cross-functional teams.
Analytical and Problem-Solving:
Expertise in analyzing complex regulatory requirements and developing proactive solutions.
Technical Expertise:
Deep knowledge of US and EU labeling regulations and global regulatory frameworks.
Proficient in authoring and reviewing product labeling documents for regulatory submissions.
Business and Organizational Awareness:
Thorough understanding of cross-functional collaboration in a global pharmaceutical environment.
Strong project management skills ensuring timely delivery aligned with business goals.
Leadership:
Proven ability to lead multidisciplinary teams, encourage open dialogue, and develop team capabilities.
Core Competencies:
Uphold Takeda values: Integrity, fairness, honesty, and perseverance.
Ethical decision-making and commitment to diversity and inclusion.
Proactive adaptability, attention to detail, negotiation skills, and effective time management.
Compensation and Benefits:
U.S. Base Salary Range: $174,500.00 - $274,230.00
Actual compensation may vary based on qualifications, experience, education, skills, and location.
About Working at Takeda:
Takeda is committed to delivering better health and a brighter future through pioneering specialty pharmaceuticals and world-class patient support programs. Certified as a Global Top Employer, Takeda fosters an inclusive, innovative, and collaborative workplace where careers thrive.
This position is classified as Remote according to Takeda’s Hybrid and Remote Work Policy.
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