VP, Medical - Boston, MA, United States - Takeda

Description

Vice President, GRA CMC, Biologics and Advanced Therapy Medicinal Products (ATMP)
Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise.

In an environment that fosters lifelong learning and a growth mindset, you'll have the support you need to thrive — at work and beyond.

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.

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

Vice President, Biologics and ATMP is a critical role within GRA, Takeda R&D, responsible for managing a complex organization that spans two critical modalities.

This role is crucial for the future of Takeda as it oversees the entire Takeda portfolio for biologics and ATMP, including cell and gene therapy products.

The individual in this role will collaborate with multiple stakeholders in R&D, GRA, GMS, Global Quality, and Commercial to develop innovative strategies for the management of development products, regulatory conformance, and pipeline management.

Manage critical portfolios for biologics and ATMP, ensuring the health and success of these portfolios for the future of Takeda.

Collaborate with stakeholders in R&D, GRA, GMS, Global Quality, and Commercial to develop innovative strategies for the management of development products.

Develop processes, systems, and infrastructure to assure regulatory conformance prospectively and retrospectively for products in the post-approval space.

Work closely with colleagues in quality and commercial organizations to manage pipeline products and bring current products to industry standards.

Represent CMC and GRA on key governance committees and play a critical role in driving the organization towards innovative approaches for the adoption and registration of new technologies and molecules.

Lead and mentor senior individuals with varying backgrounds, enabling them to hire, mentor, and develop capable individuals who can represent the organization internally and externally.

Interface with senior management, serving as the primary conduit for reporting performance against critical activities and as the voice of senior management to the team.

Resolve conformance challenges with ERT programs and serve as the liaison with senior management on the issue.

Serve as a member of the GRA-CMC Leadership team, giving input to key strategic, portfolio, human capital and financial decisions.

Provides leadership of GRA CMC Biologics & ATMP regulatory team and in conjunction with direct reports, manages resources, establish a vision, and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them.

In conjunction with members of the team, develop as well as oversee development (including updates) and communication of proactive regulatory CMC strategies to global CMC regulatory teams and stakeholders in a timely manner

Builds and manages relationships through active partnering with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics.

Ensures team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.

Build and maintain communication strategy and platform for all staff across the organization. Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet.

Actively engage and influence organization to think proactively and utilize science and risk-based approach to product development and LCM activities.

Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
Represents, as required, the regulatory function in the evaluation of new product opportunities internally and externally. Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline.

Languages:
Fluent in English (oral and written); additional languages desirable
Minimum of 20 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences
Strong leadership skills with the ability to manage ambiguity and lead teams in high-stress situations. Proven ability to collaborate with stakeholders internally and externally, including regulatory authorities.
Experience in biologics and ATMP, with a deep understanding of the industry and regulatory landscape.
Strong strategic thinking and problem-solving skills, with the ability to make informed decisions using risk-based approaches.
Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. 00

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.

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

Vice President, Biologics and ATMP is a critical role within GRA, Takeda R&D, responsible for managing a complex organization that spans two critical modalities.

This role is crucial for the future of Takeda as it oversees the entire Takeda portfolio for biologics and ATMP, including cell and gene therapy products.

The individual in this role will collaborate with multiple stakeholders in R&D, GRA, GMS, Global Quality, and Commercial to develop innovative strategies for the management of development products, regulatory conformance, and pipeline management.

Manage critical portfolios for biologics and ATMP, ensuring the health and success of these portfolios for the future of Takeda.

Collaborate with stakeholders in R&D, GRA, GMS, Global Quality, and Commercial to develop innovative strategies for the management of development products.

Develop processes, systems, and infrastructure to assure regulatory conformance prospectively and retrospectively for products in the post-approval space.

Work closely with colleagues in quality and commercial organizations to manage pipeline products and bring current products to industry standards.

Represent CMC and GRA on key governance committees and play a critical role in driving the organization towards innovative approaches for the adoption and registration of new technologies and molecules.

Lead and mentor senior individuals with varying backgrounds, enabling them to hire, mentor, and develop capable individuals who can represent the organization internally and externally.

Interface with senior management, serving as the primary conduit for reporting performance against critical activities and as the voice of senior management to the team.

Resolve conformance challenges with ERT programs and serve as the liaison with senior management on the issue.

Serve as a member of the GRA-CMC Leadership team, giving input to key strategic, portfolio, human capital and financial decisions.

Provides leadership of GRA CMC Biologics & ATMP regulatory team and in conjunction with direct reports, manages resources, establish a vision, and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them.

In conjunction with members of the team, develop as well as oversee development (including updates) and communication of proactive regulatory CMC strategies to global CMC regulatory teams and stakeholders in a timely manner

Builds and manages relationships through active partnering with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics.

Ensures team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.

Build and maintain communication strategy and platform for all staff across the organization. Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet.

Actively engage and influence organization to think proactively and utilize science and risk-based approach to product development and LCM activities.

Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
Represents, as required, the regulatory function in the evaluation of new product opportunities internally and externally. Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline.

Languages:
Fluent in English (oral and written); additional languages desirable
Minimum of 20 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences
Strong leadership skills with the ability to manage ambiguity and lead teams in high-stress situations. Proven ability to collaborate with stakeholders internally and externally, including regulatory authorities.
Experience in biologics and ATMP, with a deep understanding of the industry and regulatory landscape.
Strong strategic thinking and problem-solving skills, with the ability to make informed decisions using risk-based approaches.
Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g.

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

S.

based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

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.

Full time When you join our Regulatory Affairs team, you'll help ensure the fastest, safest path for our treatments to get to patients.

We continue building on our 240-year history as a global biopharmaceutical leader through our innovative mindset and lean governance.

Find everything you need on our Regulatory Affairs team to positively impact patients' lives while taking strides within your own.

Oversee regulatory activities
Ensure regulatory compliance
Nahid Latif - Head, Global Regulatory Affairs
Tatiana Ishida - Head of Global Regulatory Affairs, Marketed Products Group and Labeling
Nahid Latif - Head, Global Regulatory Affairs
Tatiana Ishida - Head of Global Regulatory Affairs, Marketed Products Group and Labeling
Nahid Latif - Head, Global Regulatory Affairs

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas.

Check out our pipeline and see how we'll continue delivering a steady stream of next-generation therapies.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

Inclusion
Inclusion
Innovation

Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work. Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Data & Digital
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