Director, Global Regulatory Labeling Strategy
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC.
How you will contribute :
- Management of Labeling Cross-Functional Teams
- Interface with Senior Management Cross-Functional Team (GLOC)
- Labeling Documents Authoring, Submission, and Labeling Negotiations
- Management of Local Exceptions and LOC Interactions
- Escalation Process and Stakeholder Management
- Precedent Search and Labeling Trends
- Working within Labeling Team and GRA
- People Management
- Vendor Management
- Continuous Improvement
Minimum Requirements / Qualifications :
BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred.10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and / or related experience.Strategic Thinking
Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management and in alignment with broader business objectives.Demonstrates a strong understanding of the core business aspect.Ability to effectively collaborate with global cross-functional teams and to deliver engaging and valuable presentations to diverse stakeholders.Ability to build a collaborative network of relationships across global cross-functional teams.Demonstrate strong communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation format.Ability to advocate for regulatory decisions across global cross-functional teams.Ability to actively listen to stakeholders, understanding their perspectives, addressing their concerns and formulating appropriate questions to verify their complete understanding.Analytical and Problem Solving Skills
Demonstrates deep understanding of analytical methodologies and problem-solving technique to handle complex problems.Ability to comprehend, explain, and efficiently communicate complex labeling related regulatory issues.Ability to assess complex labeling related regulatory requirements, proactively anticipate issues or opportunities and take actions before they arise, escalate to leadership, as needed, and making informed decisions aligned with portfolio priorities.Ability to proactively identify risks, develop creative solutions and risk mitigation strategies, and appropriately escalate to leadership.Technical
In-depth expertise of US and EU product labeling requirements, regulations, and guidelines.Advanced knowledge of US and / or EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape.Understanding of other relevant regional regulatory nuances and requirements.Understanding of scientific principles and regulatory / quality systems relevant to drug development.Ability to independently create, revise and / or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions.Ability to review product labeling for regulatory submissions and to provide pertinent feedback to ensure compliance with regulations and alignment with portfolio strategy and business objectives.Ability to independently develop target labeling profile (TLP).Strong understanding of global labeling processes, implications across the organization and globally, and impact of the scientific principles of quality, nonclinical and clinical data on product labeling.Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections.Business / Organizational Awareness
In depth knowledge of labeling role in project teams, and importance of cross-functional collaboration.Knowledge of organizational structure, including its functions and interdependencies.Demonstrates proactive project management skills and ability to independently deliver accurate and complete work while driving to designated timelines for the execution of submission plans, regulatory requirements and business objectives.Demonstrates a strong strategic mindset and ability to independently align global labeling strategies with broader business objectives.Ability to plan and prioritize global labeling activities and tasks for the assigned product(s) and to assign tasks appropriately.Leadership
Acts proactively and effectively as member of multi-disciplinary teams.Ability to independently and effectively lead multi-disciplinary, cross-functional teams.Displays leadership skills that foster a climate that encourages open dialogue, feedback and diverse opinion and an environment where ideas are exchanged, alignment is created and teams experiment and learn from success and failures.Accurately identifies strengths and development needs in other and invests time to help enhance the skills, quality, depth and talent of their team.Ability to distil complex issues and ideas down to simple comprehensible terms.Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.Core competencies
Demonstrates Takeda values : Integrity, fairness, honesty, and perseverance.Ethical decision making : considers the impact of decisions and actions on others, adhering to professional codes of conduct and making choices that align with Takeda values.Timeline management : ability to effectively manage self and team's time, prioritize tasks, meet deadlines and maximize team productivity.Proactiveness, adaptability and flexibility : ability to adapt to fast changing circumstances, learn new skills and work with diverse global team by being open to feedback and being able to adjust to different working styles, organizational and process changes.Attention to details : demonstrates attention to details ensuring accuracy of the labeling deliverables of the assigned product(s). Ability to the review labeling deliverables ensuring accuracy and compliance.Negotiation skills : demonstrates exceptional negotiation skills in complex situations, such as executive-level decision-making, ensuring optimal outcomes for the organization.More about us :
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location : Massachusetts - Virtual
U.S. Base Salary Range : $174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job.
U.S. based employees may be eligible for short-term and / or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national
