Accountable for establishing the strategic direction and oversight of departmental activities to assess, draft, review, finalize and maintain product labeling, as well as regulatory compliance initiatives and activities that may impact labeling strategy, throughout the product life-cycle, on a global basis.
The Director leads the regulatory activities of the Vaccine Business Unit pertaining to the development of product labeling for all global vaccine programs. She/he is an integral member of cross-functional teams to establish both the strategy and vision for labeling in support of product licensure. The Director works closely and in partnership with the Global Regulatory Program Lead, Global Clinical Lead, Pharmacovigilance and other product experts to ensure the labeling is accurate, reflective and compliant. She/he liaises with Regulatory Affairs Vaccines Regional Heads and in-country regulatory experts during label development and maintenance to ensure local requirements are met..Additionally, this role will be integrally involved in internal regulatory processes and initiatives that are driven by the product labeling, including the creation and review of externally-facing materials, product packaging and strategy for all Takeda s global vaccine candidates.
- Lead the development of labeling material through cross-functional collaboration according to agreed timelines and established processes with a Quality-driven mindset.
- Establishes and monitors compliance with internal processes, eg, implementation of CCDS information into product labeling, identifies issues and defines escalation pathways as needed.
- In coordination with stakeholders, ensures compliance-related issues are identified and resolved.
- Liaises with external partners when needed, tracks and monitors compliance to Labeling Agreements as established.
- Establishes and manages relationships with Takeda business partners and Affiliates to ensure label control, efficient label creation and continuous improvement of programs to meet business needs and regulatory requirements.
- Leads strategic planning, execution, and management of regulatory compliance projects in support of regulatory labeling submissions for various phases of product development, global marketing applications, and post-approval life cycle activities, as needed.
- Provides support to outsourced labeling activities, as needed.
EDUCATION, EXPERIENCE AND SKILLS:
- B.A. or B.S. degree required. Master s Degree in a related scientific discipline preferred.
- Minimum of 10 years of pharmaceutical/biologics-industry experience. Prior labeling experience preferred.
- Demonstrated analytical and problem-solving ability with demonstrated generation of alternative solutions prior to elevation of issues to management.
- Experience in review and approval process of pharmaceutical/biologics documentation
- Understanding of scientific principles and regulatory/quality systems relevant to drug development.
- Demonstrated attention to detail and Quality-mindset.
- Excellent oral and written communication skills.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 10% travel.
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