The Manager, Global Labeling will function as the regulatory expert for labeling on the global Regulatory Affairs (RA) Subteam to ensure that regulatory labeling requirements are met for new product submissions. Additionally, he/she is responsible for the development and maintenance of Company Core Data Sheets (CCDS) across multiple therapeutic areas in line with international standards and guidelines.
The Manager will:
- Guide the development of submission labeling for new compounds through the RA subteam, including multiple key markets (US, EU, others in line with global Regulatory Strategy).
- Prepare the CCDS for assigned compounds during the development/submission cycle, and maintain through product lifecycle.
- Oversee label content on a global basis to ensure that messages consistently meet strategic and business objectives, with appropriate supporting data.
- Manages communication plans for affiliates regarding CCDS changes and required actions based on Global Labeling Oversight Committee (GLOC) decisions.
- Support the Global Regulatory Lead (GRL) and Global Development Team (GDT) on all labeling matters.
- Develop and execute global labeling strategies in collaboration with the GRL and RA Sub team.
- Provide advice and counsel on regulatory standards for labeling during development and propose draft text for regulatory submissions.
- Author the new or revised CCDS (i.e., assimilate relevant clinical and scientific information) for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotation and supporting documentation.
- Recommend concise labeling language for inclusion in key product labels (US PI, EU SmPC, others as appropriate), consistent with information in the CCDS, when available.
- Analyze relevant competitor labeling to ensure Takeda products have the most competitive labeling possible; maintain awareness of recent in-class approvals.
- Author and manage outgoing communications regarding significant labeling change and mandatory CCDS changes for assigned products consistent with GLOC decisions.
- Maintain up-to-date information regarding global standards, initiatives by regulatory authorities related to the CCDS and labeling and assure that Takeda processes conform to regulatory requirements.
- Provide labeling strategy and guidance to affiliate Regulatory, in collaboration with the RA Sub team.
- Evaluate risks associated with CCDS content and implementation strategies, develop mitigation plans, and appropriately escalate issues to GL management and the GRL.
- Establish and manage cross-functional relationships to ensure control and continuous improvement of global labeling programs to meet business needs and regulatory requirements.
- Participate in training affiliate regulatory on relevant labeling policies and procedures, as needed.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA degree with 5 years in Regulatory or related area, 3 years experience in labeling (or similar skill set) within the pharmaceutical industry.
- Significant knowledge of global standards and regulations related to New Drug Applications, CCDS, and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred).
- Understanding of scientific principles and regulatory/quality systems relevant to drug development.
- Demonstrated problem-solving ability with ability to analyze risk and make appropriate recommendations/decisions.
- Excellent oral and written communication skills.
- Demonstrated project management, negotiation, and interpersonal skills.
- Ability to work in a team environment but can function equally well independently.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires up to 20 % travel.
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