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VP of Global Regulatory Affairs Strategy & US Regulatory Affairs

Company: Takeda Pharmaceutical
Location: Lodi
Posted on: November 12, 2021

Job Description:

By clicking the -Apply - button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda 's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description
The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. - There are two main drivers of innovation that are the focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision Medicine.

The Head of Global Regulatory Affairs (GRA) Strategy & US Regulatory Affairs ( VP), Plasma-Derived Therapies Business Unit (PDT BU) is a key leadership role in the PDT R&D organization accountable for leading global regulatory strategies across the entire portfolio of plasma-derived therapies Specifically, the Head of Global Regulatory Affairs Strategy & US Regulatory Affairs is:
Responsible for providing proactive leadership, strategic guidance and oversight the US and Global Regulatory Affairs Strategy organization by defining and optimizing global regulatory strategies, objectives, and policies for the development, registration, commercialization and lifecycle management of PDT programs globally.

Serves as the primary negotiator and liaison to the US FDA, and oversees the PDT BU 's regulatory affairs relationship with, US and International Health Authorities.

Serves as an integral member of the GRA PDT BU leadership team to help guide and influence overall business strategy of the PDT BU and foster strong and effective collaboration across the global regulatory network.

Closely collaborates with the PDT R&D and PDT BU leadership, Market Access and Commercial functions on regulatory strategy issues, bringing innovative approaches to obtain, maintain and extend Takeda PDT BU product registrations globally and help secure timely patient access.

No. of direct reports: -Number could vary from 5 to more

Provides proactive leadership and strategic guidance to the US & Global Regulatory Affairs Strategy teams and helps to guide, inform, coordinate and oversee regulatory strategy across the entire PDT portfolio of programs, working with GPTs, RA and R&D Leadership, Market Access and other commercial and business functional heads to ensure a streamlined, coordinated and global approach to regulatory strategy plans for the development, registration, market access, expansion and life cycle management of PDT programs globally.

Serves as the primary point of contact and interface with PDT R&D and BU Leadership for US and global regulatory strategy across the portfolio of marketed products and innovative development programs and provides proactive guidance to internal stakeholders based on technical and regulatory knowledge and to guide the development of strategic and tactical regulatory plans.

Serves as the primary contact point and lead negotiator with the US FDA and other international regulators to obtain timely health authority decisions, guidance and input to inform development pathways and market expansion plans across the ensure PDT portfolio globally.

Engages closely with external consultants and advisers for continuous strategic input and guidance on the regulatory landscape to ensure optimal strategies are deployed and innovative approaches are taken in obtaining, maintaining and/or extending PDT BU registrations globally.

Overseas and directs the creation of high quality, complaint regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as PIPs/PSPs, ODDs, meeting requests and briefing packages) across the PDT portfolio of programs within defined timelines as per R&D and business objectives.

Acts as the primary point of contact and interface with key PDT BU R&D functions, GPTs, market access teams and other commercial stakeholders in the preparation, review and approval of regulatory filings to support early and late-stage development assets, and the maintenance or expansion of approved PDT programs globally.

Technical/Functional (Line) Expertise
Extensive knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with global Regulatory Authorities

Demonstrated ability to develop and implement global regulatory strategies, facilitate approvals, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities

Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve commercial goals

Knowledge of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US, EU, and international markets and versed in the overarching regulatory policy landscape in which biopharmaceutical companies operate

Extensive experience in US and/or International Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways

Ability to motivate, mentor and manage a diverse team in a matrix environment

Global perspective with a demonstrated ability to work across functions, regions, and cultures

Ability to identify potential challenges and opportunities and make recommendations

Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company

Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization

Invests in helping others learn and succeed

Able to influence without authority at senior (TET/TET-1) level

Demonstrates agile leadership by seeking to understand with the ability to evolve ideas as needed.

Decision-making and Autonomy
Accountable for acting decisively and exercise sound judgment in making decisions with limited information

Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence

Ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities

Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution

Develops executable plans and meets budget and deadlines

Builds a culture of data driven decisions

Ability to challenge self and others to overcome regulatory 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

Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU

Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions

Strong communicator, able to persuasively convey ideas verbally and in writing

Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders

Disruptive thinker with the ability to influence and change how PDT used data to make decisions and set priorities

Continuously challenging the status quo and bringing forward innovative solutions

Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.

Delivers solutions to abstract problems across functional areas of the business.

Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.

Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.

Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity

Ability to provide data that will resolve or simplifies complexity between commercial, operations, and strategy

Resilient and comfortable working through large scale global change management

Minimum of 15 years of experience in global drug/biologics development in the biopharmaceutical or biotechnology industry or Government Health Authorities

Minimum of 10 years in a Regulatory Affairs role of increasing responsibilities

US and International regulatory affairs and global regulatory and/or health policy experience preferred

Experience in plasma-derived therapies or biologics preferred

Advanced scientific degree preferred (e.g., PhD, MD or JD)

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/flexible approaches to achieve commercial goals

Crisp decision-making following appropriate consultation, even in times of ambiguity

Demonstrated leadership skills and ability to inspire colleagues

Ability to motivate, mentor and manage a diverse team in a matrix environment and to influence in a matrixed environment

This job posting excludes CO applicants

Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. - US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.

EEO Statement
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.

Boston, MA

Worker Type
Worker Sub-Type
Time Type
Full time

Keywords: Takeda Pharmaceutical, Clifton , VP of Global Regulatory Affairs Strategy & US Regulatory Affairs, Executive , Lodi, New Jersey

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