Senior Manager, Global Labeling, Global Regulatory Affairs
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Senior Manager, Global Labeling in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Senior Manager, Global Labeling working on the Research and Development team, you will be empowered to take responsibility for the development, maintenance, and implementation of Company Core Data Sheets (CCDS) in line with international standards and guidelines. A typical will include:
Responsible for the development, maintenance, and implementation of Company Core Data Sheets (CCDS) in line with international standards and guidelines.
Provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory requirements.
Serve as the regulatory expert for labeling on the global Regulatory Affairs (RA) Sub team to ensure that regulatory labeling requirements are met for assigned products.
Leads cross functional teams to develop and update CCDS and other key global labeling documents (i.e. CCDS Working Team)
In coordination with Global Labeling Oversight Committee (GLOC) Chair, manages review and approval of CCDS/resolution of labeling issues with the relevant GLOC
Authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products
Evaluates risks associated with CCDS content and implementation strategies, develops mitigation plans, and appropriately escalates issues to Global Labeling management and the Global Regulatory Lead
Recommends strategies and labeling language for inclusion in key product labels (US PI, EU SmPC, JPI, others as appropriate), consistent with the overall product strategy and information in the CCDS, when available.
Provides labeling strategy and guidance to Local Operating Company (LOC) Regulatory, in collaboration with the RA Sub team.
Provides information to Global Labeling Compliance, as required, to support internal and external (i.e. Regulatory Authority) requirements and support audits/inspections as a labeling subject matter expert
Liaises with US Labeling Operations and EU Labeling Operations to ensure
labeling objectives and timelines are met
Remains current with global standards, initiatives by regulatory authorities related to the CCDS and labeling, and assures that Takeda processes conform to regulatory requirements. Propose actions as needed.
Identifies and leads initiatives, as requested, to enhance Global Labeling processes and systems. Participates in training LOC regulatory on relevant labeling policies and procedures, as needed. Prepares training materials as
EDUCATION, EXPERIENCE AND SKILLS:
BSc Degree, preferred. BA accepted.
6+ years of pharmaceutical industry experience. This is inclusive of 5 years of labeling experience or combination of 6+ years regulatory and/or related experience.
Understanding of scientific principles and regulatory/quality systems relevant to drug development.
Knowledge of global standards and regulations related to CCDS and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred).
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
Demonstrates problem-solving ability with ability to analyze risk and make appropriate recommendations/decisions.
Must work well with others and within global teams.
Acceptable and independent skills in regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identifies issues; offers creative
solutions and strategies, including risk mitigation strategies.
Willingness to travel to various meetings, including overnight trips.
Requires approximately up to 10-30% travel
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days