Head of Global Regulatory Affairs - Rare Genetics and Hematology応募後で応募 求人ID R0040047 掲載日 06/29/2021 Location:Cambridge, Massachusetts
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Head of Global Regulatory Affairs - Rare Genetics and Hematology in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Global Regulatory Affairs team member, you will be empowered to contribute to Takeda’s mission.
Core input to Global Program Team(s) throughout development programs (TA, Labeling)
Global regulatory strategy (incl. TA, filing strategy, Labeling
Global TA has asset-level responsibility for both US and EU HA interactions and procedures (including direct reporting lines)
Regional strategic input to Global Program Team(s)
Provides global regulatory oversight for assigned therapeutic area (s), focused on non-clinical and clinical aspects of drug development and associated regulations.
Develops and implements innovative, competitive global regulatory strategies from product inception to end of lifecycle and primary interface with US Food and Drug Administration; they have overall responsibility for global regulatory strategies. Global Regulatory Leads represent GRA at GPT and lead Global Regulatory Teams (GRTs)
Provide strategic regulatory input to global teams and regional cross functional teams for new product filings and business initiatives.
Responsible for the development of regional regulatory strategies that de-risk and accelerate the registration of innovative and established medicines in the EU; primary interface with EMA
Flawless execution of global registration strategies that enhance the likelihood of regulatory approval through the pursuit of novel regulatory pathways and continuous sponsor/regulatory dialog in support of EU and US business priorities
Identifies regulatory requirements and trends across therapeutic areas of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
Responsible for global regulatory development plans/strategies for all projects in TA scope (consolidated across JPN, US, EU and ROW) including ensuring clinical trial requirements for global product approval are met.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Comprehensive understanding of the pharmaceutical industry and Regulatory Affairs
Global regulatory expertise with demonstrated strong ability for collaboration and team leadership; experience leading and working with cross-cultural teams.
Experience in supporting Value Based Healthcare
Demonstrated ability to work across functions, regions and cultures
Enterprise level leadership with the ability to inspire, motivate and drive results
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 and outside the company
Ability to distil complex issues and ideas down to simple comprehensible terms
Executive leadership presence and confidence
Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
Ability to develop and drive a Global Workforce and Talent strategy for colleagues in the Global, Regional and Local organizations
Decision-making and Autonomy
Broad decision making responsibilities:
Ability to make highly complex decisions that impact the enterprise
Accountable for decision making for Global Regulatory Affairs function
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
Accountable for designing and implementing vision and strategy for designated scope
Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
Ability to effectively implement R&D’s partnership strategy
Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner
Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions, including but not limited to TAs, Bus, GPSE, LOC, Market Access, GOR
Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation
Comfortable challenging the status quo and bringing forward innovative solutions
Ability to take risks implementing innovative solutions, accelerating time to market
Ability to work in a global ecosystem (internal and external) with a high degree of complexity
Breadth of knowledge required across therapeutic areas, indications, and/or modalities
Experience operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Minimum BS degree; advanced degree (MS, MBA, PhD or MD) preferred with 12+ years of industry experience in Regulatory Affairs development with responsibilities for major aspects of strategic planning, implementation and delivery of clinical programs
Extensive experience in interacting/negotiating with US (FDA) and EU (EMEA) agencies
Senior management experience in Regulatory Affairs or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
Operational experience in pharmaceutical drug development with significant direct exposure to clinical development
Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
Health care business acumen with a comprehensive understanding of the pharmaceutical industry
Location and Salary Information:
- This job posting excludes CO applicants.
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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
EEO Verbiage for US Reqs
Takeda 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.