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Manager/Senior Manager, Global Labeling, Global Regulatory Affairs

Boston, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.

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Manager/Senior Manager, Global Labeling, Global Regulatory Affairs

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Job ID R0034654 Date posted 04/20/2021 Location Boston, Massachusetts

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Job Description

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 a Manager/Senior Manager, Global Labeling in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Manager/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:

POSITION OBJECTIVES:

  • 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.     

POSITION ACCOUNTABILITIES:

  • 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:

For Manager:

  • 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.

For Senior Manager:

  • 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.

TRAVEL REQUIREMENTS:

  • 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

#LI-KD1

This job posting excludes CO applicants.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0034654
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