Skip to main content

Vice President, GRA CMC, Biologics and Advanced Therapy Medicinal Products (ATMP)

Boston, Massachusetts
Apply Now
  • Job Level: Senior
  • Travel: Minimal (if any)

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.

At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond.

Job ID R0119124 Date posted 03/18/2024 Location Boston, Massachusetts

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’sPrivacy Noticeand 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

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.

How you will contribute:

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.

Key Responsibilities:

  • 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.

ACCOUNTABILITIES

  • Responsible for demonstrating Takeda leadership behaviors.  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.) and external stakeholders (Health authorities, Industry counterparts/associations, academia). 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.
  • Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people.
  • 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. Leads or plays a key role on the relevant internal Takeda governance committees

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

  • 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. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
  • Excellent communication skills, with the ability to communicate concisely and clearly across all levels of the organization.
  • 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. US FDA, EU, PMDA, NMPA, WHO).
  • Actively engaged in major industry associations (e.g. EFPIA, BIO, PhRMA, CASSS, PDA, ISPE, DIA) and joint regulator/industry initiatives (e.g. ICH).
  • High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$252,000.00 - $396,000.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.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. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
Apply Now

Where you fit in

When you join our Regulatory Affairs team, you’ll help ensure the fastest, safest path for our treatments to get to patients. With colleagues who encourage you to question everything for better outcomes, you’ll be part of a team that’s deeply involved across each therapeutic area, from candidate selection to post-marketing.

At Takeda, you’ll join an environment with the energy and flexibility of a startup. 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

  • Provide strategic focus

  • Collaborate cross functionally

  • Ensure regulatory compliance

Integrity is at the center of everything we do. This value is not something that you teach — it comes with the package.

Tatiana Ishida - Head of Global Regulatory Affairs, Marketed Products Group and Labeling

We sit outside of the traditional disciplines, so we’re able to get involved in everything.Our role is to distill complex information and pull insights that give us a competitive advantage.

Nahid Latif - Head, Global Regulatory Affairs

The heart of our work

Shining a light on new perspectives

Our pipeline

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.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

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.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

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.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

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

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

Exterior of Takeda Building

About our location

Boston, Massachusetts


View Map of Boston, Massachusetts

Join our talent community

Get customized job alerts sent right to your inbox. Plus, get the latest in company news and other important resources by signing up for our talent community.

Learn about job updates