The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases. The Head, Global Regulatory Affairs Strategy, Plasma-Derived Therapies Business Unit will have the ability to create and define the future vision and operating model for the team. There will be two main drivers of innovation in the newly-formed PDT R&D group:
- Translational Pharmaceutical Sciences: This innovation engine will practice rapid-cycle innovation to test and develop improvements to existing products, develop new products, and improve yield. It will combine translational research with pharmaceutical sciences and device, and will receive inputs from and into clinical research and manufacturing sciences.
- Precision Medicine: This innovation engine will focus on developing comprehensive, value-oriented health care delivery packages around drug products, targeted to maximize benefit and reduce risk to precise patient populations. In the process, this engine will drive innovation by practicing patient-centric R&D.
Under limited supervision, the Lead, Regulatory Affairs CMC/Device, Plasma-Derived Therapies Business Unit (GRA PDT BU) is responsible for developing, coordinating and implementing global CMC/Device regulatory strategies for all programs under the Lead's oversight. Specifically, the Lead, Regulatory Affairs CMC/Device is responsible for providing proactive leadership and strategic guidance to the assigned team by defining and optimizing global regulatory strategies pertaining to the development, registration, commercialization and lifecycle management of Plasma-Derived Therapies in the United States and international markets. The role will serve as the liaison to, and oversees the regulatory affairs relationship with, US and International Health Authorities for CMC/Device issues pertaining to the Lead's assigned team.
Strategic Leadership & External Interactions
- Proactively contributes to the development and implementation of innovative CMC/Device regulatory strategies in close collaboration with relevant Takeda R&D, PDT BU R&D and Commercial functions to obtain, maintain and extend Takeda PDT BU product registrations in the United States, Japan, the European Union, Canada and emerging markets.
- Maintains optimal CMC/Device Regulatory Affairs effectiveness for ongoing development and lifecycle management activities through regulatory and operational excellence within their assigned team
- Provides proactive guidance and oversight to CMC/Device Regulatory Strategists.
- Remains knowledgeable about current CMC/Device regulations and guidances and interprets the global CMC/Device regulatory environment to provide proactive guidance to internal stakeholders based on technical and regulatory knowledge and to guide the development of strategic and tactical regulatory plans. Proactively identifies and assesses regulatory and compliance risks associated with product development and life-cycle management activities.
- Creates high quality, compliant CMC/Device regulatory documents (eg, Core Dossiers, CTAs, MAAs, NDS, Variations and other relevant regulatory CMC/Device filings) within defined timelines as per Takeda PDT BU objectives. Directs such activity in their assigned team.
- Interfaces with key GMS and PDT BU R&D functions in the preparation, review and approval of CMC/Device regulatory filings to support early and late stage development assets, and the maintenance or expansion of approved Plasma-Derived Therapies globally.
- Proactively develops and fosters appropriate relationships with global regulatory agencies, especially the US Food and Drug Administration and international regulatory agencies to develop effective, professional relationships and advance a positive company image.
- In partnership with other relevant functions, assists in the conduct of regulatory agency inspections and compliance audits. Ensures compliance in all GRA PDT BU activities.
- Acts as an ambassador for the Takeda PDT BU Regulatory Affairs organization to influence and shape the external regulatory and policy environment.
PDT BU R&D Leadership
- Serves as an active member of the PDT BU CMC/Device Regulatory Affairs leadership team to help influence and execute the operations and future strategy of the Takeda PDT BU R&D and Global Regulatory Affairs organization.
- Works in a highly matrixed, GPT-oriented environment and ensures close collaboration with other PDT BU functions and relevant Takeda R&D functions to provide an effective, common approach and partnership centrally, regionally, and locally.
- Supports BioLife International Regulatory Affairs activities as directed.
Culture and People Leadership
- Recruits top talent, develops team members and direct reports.
- Focuses on people management, including succession planning and ability for workforce planning in one, three and five year timeframes.
- Ensures a culture of transparency, innovation and teamwork. Is approachable to colleagues across Takeda and is open to the ideas of others.
Education and Experience Requirements
- Minimum of 8 years of experience in global drug/biologics and/or device development in the biopharmaceutical or biotechnology industry, or Government Health Authorities.
- Minimum of 5 years in a Regulatory Affairs CMC and/or Device role.
- Experience in plasma-derived therapies or biologics preferred.
- Global regulatory CMC and/or Device experience preferable.
- Advanced degree preferred, such as PhD, MD or JD.
Key Skills, Abilities, and Competencies
- Demonstrated leadership skills and ability to inspire colleagues.
- Extensive knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with global Regulatory Authorities.
- Ability to use precedent and previous experience to develop innovative and flexible approaches to achieving commercial goals.
- Ability to challenge self and others to overcome barriers and deliver high quality solutions to the business.
- Ability to negotiate and influence without authority in a matrix environment.
- Crisp decision-making following appropriate consultation, even in times of ambiguity.
- Knowledge of the global drug discovery and development process, laws and CMC and/or Device regulations affecting biopharmaceutical development in US, EU and international markets.
- Ability to motivate, mentor and manage a diverse team in a matrix environment.
- Must be able to work in a fast paced, highly matrixed, GPT-oriented work environment with demonstrated ability to prioritize and complete multiple competing tasks and demands.
- Excellent interpersonal, communication, analytical, managerial, and organizational skills.
Complexity and Problem Solving
- A complex global role. Recommendations and decisions have significant impact on the achievement of critical functional line and PDT BU R&D and Commercial goals. Following consultation with the Head, Regulatory Affairs CMC & Device, Plasma-Derived Therapies Business Unit makes decisions on CMC priorities within a defined budget.
Internal and External Contacts
- Key contacts include Manufacturing, Quality Assurance, Supply Chain, regional and local regulatory affairs organizations, PDT BU Commercial, Medical Affairs, Clinical Research & Operations, and others. Externally, may interact directly with US, EU and EEA region regulatory agencies, Health Canada, PMDA/MHLW, international regulatory agencies, policy makers, patient and trade associations on CMC- and/or Device-related issues.
Other Job Requirements
- ~15-20% national and international travel anticipated
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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