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Ass. Director, Regulatory Lead, EUCAN

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 R0109028 Date posted 10/30/2023 Location Zurich, Canton of Zurich

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Job Description

At Takeda, we are a forward-looking, world-class R&Dorganizationthat 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 possiblein order tobring life-changing therapies to patients worldwide.

Join our exceptional team and discover a world of possibilities at Takeda! We are seeking a talented Ass. Director, Regulatory Lead, EUCAN to join our Zurich based RA development team for an exciting early phase product within R&D.

OBJECTIVE:

Define, develop, lead regional strategies:

  • to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements.

  • to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives within the therapeutic area of responsibility.

  • Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.

  • Manages interactions with EMA and national authorities in the Europe Region for products within their responsibility.

ACCOUNTABILITIES:

  • Partners with Takeda Global and Regional counterparts to define, author and lead the regional regulatory strategy considering regulatory, scientific, medical and market access guidelines and perspective.

  • Monitors and identifies regulatory requirements and trends to provide regulatory guidance and expertise to global development team and/or higher internal governance bodies.

  • Develops and maintains effective working relationships with internal Regulatory, Cross-functional Teams, consultants and/or business partners

  • Lead strategy execution for on-time achievement of regional submissions and approvals.

  • Acts as deputy to the regional therapeutic area lead and/ or regional regulatory head, attending internal leadership team meetings, when required.

  • Collaborates with global colleagues to resolve regional critical challenges impacting global regulatory strategies if applicable.

  • Proactively builds/strengthens external stakeholders relationship (Regulatory Agencies, external experts, industry organizations, etc) to achieve Takeda strategic goals.

  • Leads and coordinate preparation meetings and/or interactions with regulatory Agencies meetings negotiates on behalf of project team as necessary and represents Takeda in these meetings/interaction accordingly.

  • May be required to lead and provide regional regulatory input in due diligence for licensing opportunities, development and/or marketed products.

  • Identifies regulatory risk and proposes mitigations accordingly.  

  • Mentors team members, if required.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BSc degree is a must, advanced degree(s) preferred
  • A minimum of 8 years of pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases. 
  • Strong working experience of regulations and guidelines governing drugs and biologics in all phases of development, including post-marketing in the EU and working with centralized procedures, with a good understanding of basic regulatory requirements in emerging markets. Understanding of evidence requirements beyond the regulators (e.g. HTA bodies).
  • Solid experience in developing and leading regional regulatory strategies
  • Understanding and ability to interpret complex scientific issues across projects and therapeutic area of responsibility as it relates to regulatory requirements and strategy.
  • Preferred experience in managing multiple filings; or managing multiple programs in late development area in the EU region with global involvement
  • Generally strong in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Able to train/develop junior colleagues in regulatory strategy.

PHYSICAL DEMANDS:

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)

  • Carrying, handling and reaching for objects 

  • Ability to sit or stand for long periods of time while traveling.

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings, including overnight trips.

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

80-100%
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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

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

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

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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