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Head of Global Regulatory Affairs Development Strategy

Posted on Apr 5, 2021 by Takeda Pharmaceuticals

Boston, MA 02297
Research
Immediate Start
Annual Salary
Full-Time


Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?


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.


OBJECTIVES:


The TAK- GRAD Strategy Leader will lead the global development regulatory strategy and execution for Takeda's leading cell therapy project, TAK-. In close collaboration with the TAK- Global Project Leader, Clinical, and other key functions, the GRAD Strategy Leader will:


Define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives
Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of TAK-, while ensuring compliance with applicable regulatory requirements
Act as a leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable
Provide leadership and development for direct reports
Furthermore, the role will engage with the broader Regulatory community within Takeda and participate in global initiatives representing Regulatory in support of Takeda R&D objectives.


ACCOUNTABILITIES:


Lead the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represent GRT at project team meetings
Define strategies and provide tactical guidance to the TAK- team and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversee direct reports or junior staff responsible
Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
Demonstrate ability to anticipate risks, be responsible for developing solutions to identified risks, discuss with team and management, and understand probabilities of technical success for the solutions
Be accountable for all US FDA submissions and approvals of TAK- or oversee direct reports responsible; lead all submission types
Serve as the direct point of contact with health authorities, and lead and manage FDA/health authority interactions/meetings
Be accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance
Oversee vendor responsibility for regulatory activities and submissions for TAK-
Participate in or lead departmental and cross-functional taskforces and initiatives
Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product-specific value evidence topics, as applicable
Monitor and anticipate trends that impact both the regulatory and access environments to strengthen TAK- development plan(s) and adopt regulatory strategies in a timely manner
Be responsible for demonstrating Takeda leadership behaviors
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:


Education:


Bachelor's Degree or international equivalent required, advanced degree in a relevant scientific/clinical/regulatory field preferred
Required:


12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience. Oncology and/or cell therapy experience preferred
Preferred experience in reviewing, authoring, or managing components of regulatory submissions
Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus
Ability to understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy
Ability to understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy
Demonstration of acceptable skills with increasing independence in the area of regulatory strategy, such as understanding broad concepts within regulatory affairs and implications across the organization and globally, proactively identifying regulatory issues, and offering creative solutions and strategies
Knowledge and Skills:


Multi-faceted background with direct involvement or experience working with functions from multiple divisions
Expert knowledge in the overall pharmaceutical drug development process
Demonstrated ability to build consensus and drive resolution of issues while maintaining positive working relationships across functions; negotiation and strong persuasive abilities
Strong written and verbal Communication Skills: ability to express oneself clearly and concisely to external partners, vendors or with others within the team; ability to message key issues appropriately and document issues and/or concerns concisely and comprehensively; ability to adjust language and/or terminology appropriate for the audience; demonstrated ability to clearly and concisely communicate/present key information to senior management
Analytical and Problem Solving Skills: ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
Strategic Implementation: ability to develop, implement and monitor the overall clinical operations strategy
Leadership Skills: develops and uses knowledge and interpersonal skills to influence and guide others towards the accomplishment of Takeda's goals and objectives; requires the flexibility and tolerance to best manage change and differing opinions with diplomacy and competence
Ability to drive decision-making within a cross-functional, cross-divisional and cross-cultural, global team structure and requires global mindset and cultural awareness in working with senior leadership in other regions and in managing cross-regional projects
Ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
Ability to capture knowledge within the cross-functional, cross-divisional global organization; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use
Management of multiple tasks of varied complexity simultaneously
Ability to work in a demanding environment with aggressive project timelines
TRAVEL REQUIREMENTS:


Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required
Requires approximately 20-25% travel




Reference: 1152695169

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