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Senior Director, GRA CMC Pharmaceuticals Development Portfolio Lead

Boston, Massachusetts
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  • 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 R0135672 Date posted 09/30/2024 Location Boston, Massachusetts

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Job Description

About the role:

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 four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Director, GRA CMC Pharmaceuticals Development Portfolio Lead where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives. You will also influence changing regulations and guidance documents; interface with outside regulatory agencies and trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy.

As part of the Regulatory Affairs CMC team,  you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals.

How you will contribute:

  • Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages
  • Combines knowledge of scientific, regulatory and business issues to ensure the regulatory filings are of high quality and right first time.
  • Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation.
  • Globally influences and is generally considered a key opinion leader and resource within Takeda and externally with stakeholders in HA and in Industry.
  • Responsible for demonstrating Takeda leadership behaviors.  Serve as a member of the GRA-CMC  Pharmaceuticals Leadership team, giving input to key strategic, portfolio, human capital and financial decisions. 
  • Provides leadership of GRA CMC Pharmaceuticals – in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them.
  • In conjunction with members of the team, develop high quality clinical, commercialization and LCM submissions, using proactive regulatory CMC strategies and submit them as planned.
  • 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.

Minimum Requirements/Qualifications:

  • Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline.
  • Minimum of 15 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences
  • 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. CPC, EFPIA, BIO, PhRMA, CASSS, PDA, ISPE, DIA) and joint regulator/industry initiatives (e.g. ICH).
  • Strong communication, collaboration, negotiation, problem solving and interpersonal skills.  Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
  • Languages: Fluent in English,  additional languages desirable   
  • High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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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:

$205,100.00 - $322,300.00

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
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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


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