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 Global Regulatory Lead (GRL), Global Regulatory Affairs Strategy, Plasma-Derived Therapies Business Unit (GRA PDT BU) is responsible for developing and directing global 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 global regulatory affairs lead for one or more projects and includes leadership of the Global Regulatory Team (GRT) composed of core regulatory support functions. The GRL will serve as the primary 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 in Japan, the European Union and EEA region, Canada and emerging markets.
Strategic Leadership & External Interactions
- In partnership with others, provides proactive guidance and leadership to develop and implement 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, Japan, the European Union, EEA region, Canada and emerging markets. This includes establishment and maintenance of global 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 the US and global regulatory strategy lead 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.
- Leads Global Regulatory Team and represents PDT BU regulatory affairs function on key internal program teams.
- Coordinates cross-functional group of regulatory professionals as part of Global Regulatory Team, including but not limited to RA CMC, RA Operations, Labeling, International/LOC RA, Device RA, Advertising/Promotion and RA Intel/Policy to drive global regulatory strategies.
- Leads the tactical implementation of strategic regulatory plans for the creation and submission of regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
- Designs 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 globally.
- Directs the creation of high quality, compliant regulatory documents (e.g., CTA, MAA, NDS, Variations, ODD, PIP and other relevant regulatory filings) within defined timelines as per Takeda PDT BU objectives.
- Acts as the primary 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 globally.
- Supervised and provides proactive guidance and oversight of assigned US and International Regulatory Strategists.
- Remains knowledgeable about current regulations and guidances and interprets the global 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 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 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
- 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 drug/biologics development in the biopharmaceutical or biotechnology industry, or Government Health Authorities.
- Minimum of 5 years 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 medical degree or equivalent relevant experience preferred.
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 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, Global Regulatory Affairs Strategy, Plasma-Derived Therapies Business Unit makes 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, international regulatory agencies, policy makers, patient and trade associations.
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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