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 Manager, Global Labeling in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As 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)
- Authors new/revised CCDS for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotation and supporting documentation
- 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
- Manages process for alignment of CCDS with local labeling, including assessment of exceptions and deferrals
- Escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) for assigned products according to procedures
- 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 support 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
EDUCATION, EXPERIENCE AND SKILLS:
- BSc Degree, preferred. BA accepted.
- Minimum of 4 years of pharmaceutical industry experience. This is inclusive of 3 years of labeling experience or combination of 2 year regulatory and/or related experience.
- Basic 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).
- Demonstrates problem-solving ability with ability to analyze risk and make appropriate recommendations/decisions Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Must work well with others and within global teams.
- Acceptable and independent skills in the area of 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
- Tuition reimbursement
- 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
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.