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Senior Director, Growth & Emerging Markets - Oncology, Global Regulatory Affairs

応募後で応募 求人ID R0037278 掲載日 06/15/2021 Location:Cambridge, 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 Senior Director, Growth & Emerging Markets - Oncology, Global Regulatory Affairs in our Cambridge, Massachusetts office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a SeniorDirector, Growth & Emerging Markets, working on the Global Regulatory Affairs team, you will provide regulatory expertise and strategic leadership for multiple programs to maximize regulatory success to strengthen the product development plan, to enable patient access and to achieve appropriate price and reimbursement in alignment with program objectives, including all aspects of submission and timely approval of investigational applications, market application and life-cycle management. A typical day will include: 

OBJECTIVES:

  • Oversees the Growth and Emerging Markets (GEM) Regulatory Affairs (RA) team supporting Takeda’s Global Brands and pipeline, ensuring optimal communication with global, regional and local cross functional teams and maximum alignment among programs.

  • Provides leadership and development for multiple direct reports.

ACCOUNTABILITIES:

  • Be a role model in the organization, consistently demonstrating Takeda leadership behaviors.

  • Contributes strongly in a multi-functional team environment; provides leadership and oversight of GEM strategies to maximize regulatory success towards achievement of program objectives.

  • Fosters strong partnerships with the Global RA CMC team, partner Therapeutic Area Leaders, Global Program Leaders and other Global Program Team members in Takeda R&D, and with key stakeholders in the GEM Business Unit.

  • Demonstrates agility and resilience; helps the GEM RA team adapt to Takeda’s evolving needs, new challenges and the external environment

  • Facilities the preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of all programs within the assigned Therapeutic Area.

  • Directs GEM Regulatory Leads toward flawless communication of all regulatory aspects related to assigned Therapeutic Area.

  • Stays current with regulations and guidance’s  that impact drug development plans, registration and life-cycle management, Leverages this knowledge to provide direction to the team to ensure optimal regulatory strategy implementation for Takeda’s drug development initial marketing applications and life-cycle management in Growth and Emerging Markets,

  • Provides regulatory expertise for multiple programs within core therapeutic area, focused on all aspects of drug development, registration,  post-marketing compliance and life cycle management. 

  • Develops effective working relationships with GEM BU Area RA Heads,  Local Regulatory Leads of GEM Core Countries, Global Regulatory Teams, and Cross-functional Teams at the Global and GEM Regional level; and Takeda’s partner consultants and Business Partners.

  • Provides regulatory support to Takeda’s Access to Medicines initiatives to help develop and implement innovative patient access strategies.

  • Supports the evaluation of new business development opportunities for Growth and Emerging Markets.

  • Provides timely updates  to GRA  and GEM BU senior leadership and teams on emerging trends, regulations and changes, with emphasis on those related to his/her therapeutic area of responsibility enabling proactive approach and planning to support Takeda’s current and future business needs.

  • Oversees interactions with Health Authorities in Growth and Emerging Markets countries for all programs in defined Therapeutic Area scope

  • Interacts with Health Authorities, as required. Represents Takeda GEM RA in Health Authority meetings, as required.

  • Provides leadership and development for multiple direct reports for the design and execution of regional regulatory strategies in collaboration with their local counterparts.

  • Focuses on and plans for talent retention and development in the GEM RA team.

  • Fosters a proactive, collaborative and goal-driven organization.

  • Partner with the regional/LOC market access and LOC RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/Health Agency on value and evidence topics and to support health authority decision making. Collaborate with EUCAN RA on value and evidence generation and relative effectiveness topics to support patient access.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • BS degree in a scientific discipline; BA accepted based on experience. Advanced degree preferred. 

  • Extensive pharmaceutical industry experience.  This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and post-marketing phases.

  • 12 plus years of directly related regulatory experience.

  • Extensive regulatory experience, including knowledge of regulations and guidance’s governing drugs and biologics in all phases of development for emerging markets and US and/or EU (relevant to role) as well as leading interaction with Health Authorities.

  • Preferred experience in managing multiple filings; or managing multiple programs across therapy areas in closely related development area; global involvement also preferred.  Must be able to provide guidance in interpreting regulatory regulations and guidelines. Must be able to formulate global regulatory strategy to achieve competitive and accelerated product approvals.

  • Solid understanding and ability to interpret complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements and strategy. 

  • Analytical, strategic thinker with proven leadership ability that demonstrates professionalism and establishes respect with excellent people management skills.  Demonstrated ability to develop others in regulatory strategy, including as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offering creative solutions and strategies, including risk mitigation strategies.

  • Excellent written, communication, project management and presentation skills (articulate and persuasive). Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships

  • Ability to influence others, at all levels of the organization, without direct hierarchal authority, and affect change across organizational boundaries.  Ability to collaborate effective with peers, within global teams and in communicating with senior leadership.

  • Must be a  strong leader that inspires and motivates the team.  Takes clear positions on important issues in a productive and respectful manner.

  • Has a passion to develop others, consistently looking for avenues to develop his/her team and share knowledge and best practice with stakeholders and partner functions and teams.

  • Experienced in managing multiple personnel for multiple years as well as experience managing relationships with CROs and/or contractors.

Job Posting excludes CO applicants

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

Empowering Our People to Shine

Learn more at takedajobs.com

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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