Regulatory Affairs Manager, Rare Diseases (EUCAN - Europe & Canada)
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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Life at Takeda
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Procurement Lead, Northern Europe
“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.”
Regional Head, Europe, Vaccines
“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.”
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.
Regulatory Affairs Manager, Rare Diseases (EUCAN - Europe & Canada)Apply Now
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Regulatory Affairs Manager (Rare Diseases) for EUCAN in our Zurich office
An opportunity has arisen to join our EUCAN region regulatory affairs team in Zurich as a Regulatory Affairs Manager (strategist) for Rare Diseases. As well as the responsibility for assigned products, ensuring regional regulatory lifecycle management strategy and ensuring submission planning is written and executed according to plan, the position will also work on products still in clinical development.
Key skills required
- Desire to put people first and demonstrate the values of Takeda-ism
- BS degree or equivalent in science; an advanced degree would be advantageous
- Experience within the pharmaceutical industry including direct experience in regulatory affairs in development and /or post-marketing phases.
- Working knowledge of regulations and guidance governing drugs and biologics in development, including post-marketing in the EU. A good understanding of basic regulatory requirements in emerging markets is a plus. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)
- A strong interest in rare diseases and/or associated experience (e.g. accelerated processes) would be highly advantageous.
- Understands and interprets complex scientific issues and capability to relate to regulatory requirements and strategy.
- Proven regulatory submissions capability in Europe, while experience in Canada would be helpful
- Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Able to demonstrate skill(s) in the area of regulatory strategy such as understanding 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.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realise their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.
What Takeda Can Offer You
To further support and inspire our employees, our benefits include: Competitive basic salary, Annual Bonus, Contributory Pension Scheme, Private Health Cover and Life Assurance.
Empowering Our People to Shine
Learn more at takedajobs.com
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Job ID SR0041835