Head of Global Regulatory Affairs Labeling
3 days ago
We are seeking a highly skilled and experienced professional to lead our Global Regulatory Affairs Labeling team. As the Head of Global Regulatory Affairs Labeling, you will be responsible for providing strategic guidance and oversight for the global labeling function, ensuring compliance with regulatory requirements and guidelines.
Key Responsibilities- Develop and implement global regulatory strategies for labeling, ensuring alignment with business objectives and regulatory requirements.
- Lead cross-functional teams to achieve regulatory approvals and ensure compliance with labeling regulations.
- Provide expert advice on labeling requirements, templates, and tools to internal stakeholders.
- Collaborate with regional Regulatory Heads to ensure consistency in labeling practices across regions.
- Develop and maintain relationships with Health Authorities to ensure timely and effective labeling approvals.
- Identify and mitigate regulatory risks, ensuring compliance with labeling regulations and guidelines.
- 10+ years of pharmaceutical industry experience, with a focus on regulatory and/or labeling experience.
- Advanced scientific degree (MSc, PhD, or PharmD) a plus.
- Strong leadership and communication skills, with the ability to influence and motivate cross-functional teams.
- Ability to work in a matrixed environment, with a high degree of complexity and ambiguity.
- Travel up to 20%.
Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are committed to delivering Better Health and a Brighter Future to people around the world.
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 our mission.
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Cambridge, Massachusetts, United States Takeda Full timeAbout the RoleWe are seeking a highly skilled and experienced Head of Global Regulatory Affairs Labeling to join our team at Takeda. As a key member of our Plasma-Derived Therapies (PDT) R&D Organization, you will be responsible for providing guidance and oversight for the global labeling function.Key ResponsibilitiesDevelop and implement global regulatory...
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