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Director, Regulatory Affairs Vaccines CMC - Vaccine Business Unit

 

Success Profile

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

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Engage Others Motivates and influences others to gain support for ideas, strategies and actions in service to providing superior pharmaceutical products to patients; provides appropriate background so that messages are meaningful with audiences.

Collaboration Establishes productive relationships and partners with others across the organization to ensure common understanding of objectives and achieve shared goals.

Drive for Results Holds self and others accountable for delivering on commitments that align with our short- and long-term goals, never forgetting the end result is to help patients through innovation in medicine.

Strategic Approach Makes sound decisions that are consistent with our mission, values and organizational objectives.

Lead Change Proactively evaluates, promotes, and initiates change that creates value for patients, the organization, and our shareholders.

Self Awareness Seeks feedback from others, modifies self-perceptions and actions based on this feedback, and actively develops skills and behaviors to enhance contribution.

Develop Capabilities Seeks opportunities to develop oneself and others so that we can continue to achieve sustained growth.

Rewards

  • Teamwork

    Takeda builds strong, borderless and empowered teams through fairness and promoting shared goals. By working together, we optimize energy and can lead the change for a better world.

  • Innovation

    Takeda implements bold initiatives on a daily basis by striving for continuous improvement and encouraging enthusiasm and creativity. This value speaks to attracting the best minds in the industry that are committed to delivering novel therapies to patients worldwide.

  • Diversity

    Takeda respects and includes a broad range of people and ideas in its daily operations. Our organization encourages each individual to act with empathy and to apply their unique skills to realize the company’s true potential.

  • Passion

    Takeda's drive comes from perseverance, urgency and a strong desire to contribute to patients. We put this passion to work in everything we do and demonstrate courage to fight for ideas and objectives to raise the quality of our solutions, create stronger ties with our stakeholders, and deliver results.

  • Commitment

    Takeda works to meet its responsibilities to stakeholders on a daily basis. We provide adequate support and challenge to ensure we deliver high-quality solutions that help more people around the world.

  • Transparency

    Takeda appropriately shares information and promotes honest, sincere dialogue with stakeholders to build trust. This trust enables us to strengthen our relationships with employees and external communities.

Videos

  • Takeda Oncology

  • Inspired by Patients

  • Corporate Citizenship Activities

News and Events

  • Moving Mountains

    Moving Mountains My Story and Why I’m Climbing
    I oversee Corporate Communications at Takeda Oncology, a company committed to discovering and developing treatments for patients with cancers

    Moving Mountains
  • One Vision: We aspire to cure cancer.

    Takeda Completes Acquisition of ARIAD Pharmaceuticals, Inc., significantly enhancing our global oncology portfolio and reinforcing our commitment to develop medicines for patients living with cancer.

  • Our communities

    Rushing Toward a Cure (RTC) launched in 2006 in partnership with the Patriots Radio Network (WBZ 98.5) and our local chapter of the Leukemia & Lymphoma Society (LLS). With RTC, Takeda Oncology contributes a set financial donation to the LLS for every 100 rushing yards gained by New England during the pre, regular and post-seasons. This money helps fund vital blood cancer research, patient services and education programs.

Overview

More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.

Takeda Pharmaceuticals U.S.A., Inc. ranks among the top 15 pharmaceutical companies in the United States. Our larger U.S. offices are in Cambridge, MA, Deerfield, IL, and San Diego, CA. Research & Development employees in our Cambridge location focus on oncology, gastroenterology, immunomodulation, biologics, translational research, and external innovation. In March 2016, we opened our newest space at 300 Massachusetts Avenue, featuring 230,000 square feet of state-of-the-art office and lab space.

While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, 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!

Responsibilities

OBJECTIVES:
  • Provides program leadership and develops CMC regulatory strategy to global vaccine programs in various stages of development.  Strong focus on analytical, manufacturing, and facilities compliance. 
  • Represents the vaccine regulatory affairs team on cross-function Takeda Vaccines teams (commercial, clinical development, delivery, quality, etc) to ensure that data are identified, obtained and effectively presented for the registration of products world-wide.
  • Demonstrates leadership and comprehensive understanding of global vaccines CMC regulations and guidelines by applying interpersonal skills and expert RAV CMC knowledge to identify, communicate, address, and overcome challenges that arise during development and commercialization.  Conduct routine regulatory surveillance and coordinate comments on new/changing regulations globally.
  • Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.

ACCOUNTABILITIES:

  • Leads planning, execution, and management of regulatory submissions for assigned vaccines in various phases of clinical development, global marketing applications, and post-approval life cycle activities, as needed
  • Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization
  • Leads regulatory compliance assessment with respect to filing requirements for assigned vaccines throughout development and the commercial life cycle
  • Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
  • Represents Takeda RAV CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
  • Interacts directly with international Health Authorities, as required.  Participates in and/or leads agency meetings
  • Ensures project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner
  • Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
  • May serve as direct/matrix manager of up to 4 RAV CMC staff, depending on project.  Responsible for prioritization of workload and professional development of staff
  • Other duties as needed
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BS/BA Degree in a scientific/engineering discipline required, Advanced Degree preferred.
  •  10 + years Regulatory CMC experience (vaccines or biologics experience required). Alternatively 5+ years Regulatory CMC experience combined with 5+ years relevant vaccines or biologics experience (e.g. Pharmaceutical Development, Process Development, Analytical Development, Production, Quality Assurance).
  • Proven ability to liaise with Regulatory Agencies in Agency Interactions and product development meetings, global experience preferred.  Demonstrated track record for successful interactions with FDA and preferably other global health authorities related to CMC submissions.
  • Understanding of scientific principles and regulatory CMC requirements relevant to global vaccine development, registration, and post-market support.  Proven ability to provide strategic regulatory guidance to teams.  Experience with managing BLA/MAA content and format required.
  • Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
  • Demonstrated leadership, problem-solving ability, flexibility and teamwork.
  • Experience with process development, analytical characterization, process scale-up and/or regulatory registration of biological drug substances or drug products (including sterile parenteral dosage forms) is required.
  • Exercises good judgement in elevating and communicating actual or potential regulatory risks to teams and line management.
  • Excellent written and oral communication skills required.
  • Active participation in Agency/Industry groups/forums preferred.

PHYSICAL DEMANDS:

  • Manual dexterity to operate office equipment (i.e. computers, phones, etc.)
TRAVEL REQUIREMENTS:
  • Up to 30%, as needed .  Some international travel required.


we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

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