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. 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.
The US/International Regulatory Strategist, Global Regulatory Affairs Strategy, Plasma-Derived Therapies Business Unit (GRA PDT BU) works under the direction of the Global Regulatory Lead to develop and implement regulatory strategies, objectives and policies pertaining to the development, registration, commercialization and lifecycle management of Plasma-Derived Therapies in the United States and international markets. This role serves as the US and International regulatory affairs subject matter expert for one or more projects and participates in the Global Regulatory Team (GRT) composed of core regulatory support functions. The US/International Regulatory Strategist serves as the liaison to the US FDA and will provide support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health Authorities, including Japan, Canada, EEA and growth and emerging markets (GEM).
Strategic Leadership & External Interactions
- In partnership with others and under the direction of the GRL, develops and implements innovative regulatory strategies in close collaboration with relevant PDT BU R&D, Takeda R&D and Commercial functions to obtain, maintain and extend Takeda PDT BU product registrations in the United States. This includes establishment and maintenance of regulatory strategy plans in close coordination with the PDT BU CMC Regulatory Affairs and EU Regulatory Strategy functions and the Takeda Payer Value and Patient Access function.
- Serves as a US and International regulatory strategy subject matter expert for assigned projects. Serves as a US and International regulatory strategy subject matter expert for assigned projects. Provides proactive guidance to Takeda PDT BU R&D and Takeda R&D internal functions based on technical and regulatory knowledge. Proactively identifies, assesses and mitigates regulatory risks associated with product development and maintenance for assigned projects.
- Participates in Global Regulatory Team and represents PDT BU regulatory affairs function on select internal program teams
- Assists in the coordination of cross-functional group of regulatory professionals as part of the Global Regulatory Team, including but not limited to RA CMC, RA Operations, Labeling, EU RA, Device RA, Advertising/Promotion and RA Intel/Policy to drive global regulatory strategies.
- Drives the tactical implementation of strategic regulatory plans for the creation and submission of regulatory documents, e.g., INDs, NDAs/BLAs, supplemental NDAs/BLAs, CTAs, Marketing Applications, and other relevant regulatory filings.
- Develops and implements US regulatory strategies to obtain and maintain INDs and NDAs/BLAs, and to extend product registrations.
- Coordinates and supports the design and implementation of international regulatory strategies to obtain, maintain and to extend product registrations internationally.
- Drives the creation of high quality, compliant regulatory documents within defined timelines as per Takeda PDT BU objectives.
- May serve as direct liaison to the US FDA. Provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health Authorities, including Japan, Canada, EEA and growth and emerging markets (GEM).
- Acts as a point of contact and interface with key PDT BU R&D functions in the preparation, review and approval of regulatory filings to support early and late stage development assets, and the maintenance or expansion of approved Plasma-Derived Therapies in the US and internationally.
- Remains knowledgeable about current regulations and guidances and interprets the 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.
- Proactively develops and fosters appropriate relationships with regulatory agencies, especially the US Food and Drug Administration, 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. Helps ensure 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 Regulatory Affairs team to help influence 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
- Actively contributes to 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 3 years of experience in drug/biologics development in the biopharmaceutical or biotechnology industry, or Government Health Authorities with at least 1 year of experience in a Regulatory Affairs role.
- Experience in plasma-derived therapies, biologics, drug safety, pharmacovigilance and/or risk management preferred.
- US and International regulatory affairs and global regulatory or health policy experience preferable.
- Bachelor s or Master s degree required. Advanced scientific or health sciences degree or equivalent relevant experience preferred.
Key Skills, Abilities, and Competencies
- Advanced knowledge of global regulatory requirements and ability to interface with global Regulatory Authorities.
- Ability to use precedent or 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.
- Awareness of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US and international markets.
- Ability to work as part of a diverse team in a matrix environment.
- Must be able to work in a fast paced, highly matrixed, GPT-oriented work environment with ability to prioritize and complete multiple competing tasks and demands.
- Excellent interpersonal, communication and analytical skills.
Complexity and Problem Solving
- An advanced global role. Recommendations and decisions directly impact the achievement of critical functional line and PDT BU R&D and Commercial goals. Following consultation with the Global Regulatory Lead, Global Regulatory Affairs Strategy, Plasma-Derived Therapies Business Unit implements decisions on priorities within a defined budget.
Internal and External Contacts
- Key contacts include global, regional and local regulatory affairs organizations, PDT BU Commercial, Medical Affairs, Clinical Research & Operations, Compliance and Pharmacovigilance, Payer Value and Patient Access functions. Externally, may interact directly with US, EU and EEA region regulatory agencies, Health Canada, PMDA/MHLW and international regulatory agencies.
Other Job Requirements
- ~10-20% national and international travel anticipated
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