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Associate Director, Device and Drug-Device Combinations Strategic Sourcing Operations

Zurich, Canton of Zurich
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  • Job Type: Full Time
  • 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 R0134353 Date posted 10/28/2024 Location Zurich, Canton of Zurich

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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:

OBJECTIVES:

  • Responsible for end-to-end management including liaising, coordinating, providing oversight for device and drug-device combination work outsourced by the Global Regulatory Affairs CMC Device and Drug-Device Combinations to external partners
  • Utilizes regulatory strategy and/or operational expertise and lessons learned to shape global regulatory best practices, drive internal consistency and influence effective change management
  • Builds and manages strong working relationships through active partnering with key internal and external stakeholders

ACCOUNTABILITIES:

  • Responsible for demonstrating Takeda leadership behaviors
  • Serves as primary Global Regulatory Affairs CMC Device and Drug-Device Combinations contact for sourcing partners on select programs and cross-program work.  This includes but is not limited to compliance/maintenance roles on the device (constituent) such as annual reports, renewals, relevant health authority listings, procurement of documentation (legalization, declaration of conformity, other certificates, etc.)
  • Proactively identifies combination product and device-related regulatory risks, ensuring timely communication with line management
  • Supports as needed, assigned work on drug-device combination aspects of regulatory submissions (e.g., CTAs, registrations, Variations, Technical Files, Notified Body Opinions, CE marking, etc.) in collaboration with sourcing partners
  • Serves as point of contact for support from sourcing partners on audits and investigations
  • Develops and maintains constructive relations with key internal and external colleagues.

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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BS/BA Degree in a Scientific, Pharmaceutical or Engineering Discipline.
  • 8+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a regulatory representative for drug-device combination products
  • Experience working on cross-functional submission teams
  • Solid understanding and proven ability to provide strategy on regulatory requirements relevant to global drug-device combination product development, registration and post-market support
  • Experience supporting interactions with EMA, Notified Bodies and other global health authorities specifically related to Combination Products and Device submissions (e.g., CTA, IMPD, MAA, 510(k), Notified Body Opinions, Technical File submissions, etc.) is strongly preferred
  • Demonstrates emerging leadership, problem-solving ability, flexibility and teamwork
  • Exercise good judgement in elevating and communicating actual or potential issues to line management
  • Excellent written and oral communication skills are required, with cross-organization stakeholder engagement
  • Ability to self-direct within a project team and properly manage tasks and work expectations, lead, be influential and effective, collaborate with GRA Liaisons, GRA CMC Leads and other regulatory functions, driving drug-device combination strategy for EU & Global Markets
  • Able to deal with issues of critical importance, provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings or events, including overnight trips. Some international travel may be required.
  • Requires approximately 10% travel

Locations

Zurich, Switzerland

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 Development, Labeling and Advertising & Promotion

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

Zurich, Canton of Zurich


View Map of Zurich, Canton of Zurich

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