Senior Manager, Regulatory Affairs-Labeling

Company: Takeda
Location: Boston
Posted on: February 18, 2025

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionOBJECTIVES/PURPOSE

• Assist in preparation, formatting and QC check of Labeling Documents (Company Core Data Sheet (CCDS), USPI and SmPC) for cross functional team review including post-GLOC (Global Labeling Oversight Committee) endorsement.
• Understand the labeling regulatory strategy on the Global Regulatory Team (GRT) to ensure that regulatory labeling requirements are met for assigned products.
• Manage preparation and finalization of labeling activities/event(s), labeling documents, CCDS updates, justification documents in the appropriate eDMS systems, including the initiation and coordination of art works in FOCUS and management of the overarching change control in TrackWise.
• Track and manage the local exceptions and deferral requests in submission tracking system.ACCOUNTABILITIES
  • Manages and tracks CCDS versions in the eDMS; participates and provides advice at cross-functional labeling process discussions on the eDMS; maintains updated metadata for all CCDS versions in the eDMS; responsible for up-to-date content for labeling reports.
  • Provides operational support for the preparation of the CCDS for cross functional team review, transfers CCDS into latest CCDS template, confirms 100% content transfer, and highlights to Global Labeling Lead (GLL) possible areas for functional team review. Ensures formatting and QC of the updated CCDS including post-GLOC endorsement.
  • Prepares, formats and QCs the USPI and SmPC labeling documents in alignment with the approved and updated language from CCDS.
  • Consistency checks between CCDS and justification document, reviews documents to ensure changes in the CCDS are reflected accurately in the justification document. Uploads CCDS and justification documents to the eDMS. Coordinates with EU QPPV and Global Labeling Head or delegate, initiates workflows for CCDS and document approval in eDMS.
  • Maintains up to date labeling metadata for Vaccine products in the eDMS; liaises with the MEDIVA RIM team to review labeling reports and ensures appropriate reports are implemented for VBU labeling. Ensures updated reports are available for audits and inspections.
  • Prepares and finalizes Event(s) in submission tracking system, creates Global Project Plan (GPP), tracking ID in TRAIL, and updates GPP and tracking ID after approval of CCDS in eDMS.
  • Provides support to Local Affiliates for Labeling activities, including but not limited to responses to health authorities requests, and review of local labeling exceptions and deferrals.
  • Updates the eDMS and submission tracking system with deferral requests and local exceptions, archives deferral forms, and updates Event details.
  • Participates in ad-hoc activities such as taking meeting minutes for labeling and cross functional team meetings, document Label reviews, labeling compliance activities, label comparison tables, GL Mailbox triage.
  • Liaises with US Labeling Operations and EU Labeling Operations to ensure labeling objectives and timelines are met.EXPERTISETechnical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
    • Strong knowledge of business area, regulatory environment, and ability to identify and proactively manage the interactions necessary for achieving business goals and objectives.
    • Demonstrated knowledge of global health authorities, regulations, product approval, labeling, and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices.
    • Breadth of knowledge across end-to-end labeling process, functions, and stakeholders.Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
      • Demonstrated ability to work across functions, regions and cultures.
      • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing.
      • Proven skills as an effective team player who can engender credibility and confidence within cross-functional teams.
      • Ability to distil complex issues and ideas down to simple comprehensible terms.
      • Ability to work in a global ecosystem (internal and external) with a high degree of complexity.Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
        • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions.
        • Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution.Interaction (The span and nature of one's engagement with others when performing one's job, internal and external relationships)
          • Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties. Comfortable challenging the status quo and bringing forward innovative solutions.
          • Effectively manage complex topics and a matrixed environment, building strong relationships with stakeholders enterprise-wide.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
            • BS Degree in a science discipline. Advanced degree preferred, but not required.
            • Pharmaceutical industry experience preferred.
            • 1-2 years of regulatory and/or related experience preferred.
            • 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 preferred).
            • Strong oral and written communications with individuals at all levels of the organization and comfortable presenting to small and large groups.
            • Ability to prioritize while managing multiple projects of varied complexity and criticality and to adhere to timelines while demonstrating negotiation skills, integrity and adaptability.
            • Demonstrates problem-solving ability with ability to analyze risk, think strategically, and provide appropriate recommendations/decisions.
            • Strong interpersonal skills combined with cultural sensitivity for successful global collaboration.
            • Focus on accuracy and strong attention to detail is a must.
            • Willingness to provide and receive constructive feedback.
            • Self-motivated, self-starter with the ability to work independently and in a team with a flexible mindset.Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.For Location:Boston, MAU.S. Base Salary Range:$133,000.00 - $209,000.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.U.S. based employees may be eligible for short-term and/or long-term incentives.U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Keywords: Takeda, Boston , Senior Manager, Regulatory Affairs-Labeling, Executive , Boston, Massachusetts