Manager, Clinical Trial Regulatory Lead

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 R0122674 Date posted 06/10/2024 Location Zurich, Canton of Zurich

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Job Description

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.

Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

Objective / Purpose:

Develops the operational implementation plan for clinical trial applications (CTAs) in EUCAN and GEM regions from initial submission throughout lifecycle, in alignment with the global submission strategy. This may concern trials across a variety of Therapeutic Areas, including oncology, gastrointestinal and inflammation, marketed products and neuroscience.
Executes or oversees all activities related to the creation, submission, and maintenance of CTAs Globally (GEM and EUCAN region), in Europe through the EU Clinical Trial Information System (CTIS) or legacy processes in conformity with legal requirements and with Takeda’s global and regional internal procedures.
Ensures oversight and tracking of CTA activities and eTMF updates performed by the CRO Regulatory Lead. Works in collaboration with CRO to ensure compliance.

Accountabilities:

Demonstrates Takeda leadership behaviors.
Collaborates with Takeda Global and Regional counterparts, as applicable to manage all aspects of assigned CTA regulatory activities throughout the development lifecycle.
May present regional CTA regulatory strategies to leadership/senior management
Identifies regional/national requirements to support submissions of CTAs to Regulatory Authorities.
Coordinates submission preparations process and creation of administrative documents to support initial CTAs and/or maintenance submissions (in collaboration with CROs where applicable), ensuring all necessary documentation is made available for submission and internally approved as appropriate.
Develops and maintains standardized communication/tracking/planning tools and templates for internal use.
Ensures accurate and timely submissions and communication of key regulatory milestones throughout clinical trial lifecycle (e.g., submission and approval of initial CTA, amendment/modification, HA questions/responses etc.).
Provides regulatory oversight of CRO activities as applicable to ensure that all submissions activities are tracked, and appropriate systems are maintained in a compliant manner (e.g., eTMF).
Supports non routine submission activities and deviation follow-up as needed (e.g., provision of Serious Breach submissions, submission of inspection reports, ad-hoc unexpected filings etc.).
Upon request, provides ad-hoc guidance to teams related to latest submission requirements and experiences for clinical trials.
Works as part of team to provide proactive solutions to problems arising during the CTA processes in conjunction with senior team member and/or Global/EU Regulatory Lead, as applicable.
Supports the maintenance of appropriate internal knowledge base on emerging information and trends with regulators for clinical trials.
Participates, as appropriate, and authors/reviews internal procedures and processes.

Education & Competencies (Technical and Behavioral):

BSc. Advanced scientific related degree preferred; BA accepted based on experience.
A minimum of 4 years of experience in drug regulatory affairs preferably within the EU/GEM region.
Experience with EU CTR will be advantageous.
Solid regulatory experience, including knowledge of CTA regulations and guidance governing drugs and biologics in all phases of development for [Emerging markets and/or EUCAN Markets (relevant to role)].
Has basic regulatory procedure knowledge with major health authorities in the region.
Analyzes issues with attention to detail and makes reasoned recommendations.
Promotes an inclusive culture and expresses empathy for others.
Is able to carry out assigned activities within reasonable time.
Adapts to changing circumstances and is able to build and maintain relationships.
Receives and gives feedback; expresses ideas, questions, and disagreement.
Is self-aware and able to function effectively while meeting the multiple challenges of daily life with a sense of energy, vitality, and confidence.
Fluency in English.

Empowering our people to shine

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

Learn more at takedajobs.com

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 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.

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