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Senior Manager, EUCAN Regulatory Lead, GI

Zurich, Switzerland

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

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Success

What makes a successful member of our team?

We take action and make decisions by focusing on our four priorities in this order:

  • 1

    Putting the patient
    at the center

  • 2

    Building trust
    with society

  • 3

    Reinforcing our
    reputation

  • 4

    Developing the
    business

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Life at Takeda

  • Our People

    Our people

    To keep delivering new value to patients, we provide growth opportunities for every employee according to their abilities and passions, and together are building a stronger organization.

  • Anders Tellefsen

    Procurement Lead, Northern Europe

    Anders Tellefsen
    “Takeda is a unique place to work as there is no ‘every-day routine’ around here – it’s very a dynamic environment where change of plans and adjustments of approach are the constants... This allows for interesting cross-function collaboration and – if you’re up for it - a high degree of influence on your daily job and workplace.”
  • Yves Leurquin

    Regional Head, Europe, Vaccines

    Susan Tillman
    “Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world.”

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Opportunity

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

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

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

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with 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.

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Senior Manager, EUCAN Regulatory Lead, GI

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Job ID R0035211 Date posted 05/05/2021 Location Zurich, Switzerland

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Job Description

OBJECTIVE:

  • Under supervision from a senior team member and/or Line Manager defines, develops and sometimes leads regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives
  • Effectively communicates objective assessments of the likelihood of success of these regulatory strategies
  • Provides regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
  • Leads the Regional Working Team and represents the region as needed on global and project teams
  • Provides regional regulatory expertise for assigned development and /or life cycle management projects within the therapeutic area of responsibility
  • Under supervision from a senior team member and/or Line Manager sometimes manages interactions with EMA and national health authorities (and HTAs in context of parallel consultation) in the European Region for product(s) within their responsibility.

ACCOUNTABILITIES:

  • Ensures regional regulatory strategies are written, reviewed and executed according to plan
  • In alignment with line manager, provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
  • Manages, plans, and executes regional regulatory submissions within the area of responsibility and ensures timely approvals throughout product development and lifecycle
  • Partners with the regional market access and LOC RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authority decision making
  • Collaborates with Takeda Global and Regional counterparts and Integrated Franchise Team (IFT) to ensure the regional regulatory strategy is created and executed upon for all projects within area of responsibility
  • Identifies relevant regional regulatory requirements and trends across scope of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas
  • Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to area and region of responsibility
  • May be called upon to provide direction to senior leadership, as relevant
  • Develops and maintains effective working relationships with EUCAN RA and GI and/or NS Team members, LOC RA teams, Global Regulatory Teams, Cross-functional Teams; consultants and business partners as required
  • Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility
  • Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed
  • In collaboration with global colleagues, works to resolve regional critical conflicts in global regulatory strategies. 
  • Authors and oversees execution for more complex regional regulatory strategies as needed
  • Under supervision from a senior team member and/or Line Manager, sometimes leads and manages meetings and / or interactions with regulatory authorities and agency meetings; in alignment with line manager can negotiate on behalf of project team as necessary.
  • Under supervision from a senior team member and/or Line Manager, sometimes represents Takeda in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps
  • May be required to lead and provide regional regulatory input in due diligence for licensing opportunities, development and /or marketed products
  • Pro-actively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to support Takeda strategic goals and objectives
  • Identifies regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and /or higher governance bodies in these areas
  • Ensures coverage for projects within the therapeutic area identifies possible gaps, and proposes solutions to the management
  • Presents regional regulatory strategies to senior management as applicable

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BSc. Advanced scientific related degree preferred; BA accepted based on experience.Advanced degree preferred
  • Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases.
  • Solid working knowledge of regulations and guidelines governing drugs and biologics in development, including post-marketing in the EU
  • Understands and interprets complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy
  • Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in the EU region (as relevant to role) with global involvement also preferred
  • Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
  • Able to understand broad concepts within regulatory affairs and implications across the organization and globally
  • Proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
  • Generally strong in working well with others, within global teams and communicating with senior leadership.
  • Takes stand on important issues in productive, respectful way.
  • Experience managing relationships with CROs and/or contractors also preferred.

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0035211
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