Job Description & How to Apply Below
Assoc. Dir. Regulatory Affairs, Rare Diseases (EUCAN - Europe & Canada)
Apply Now Job ID
SR0041840 Date posted
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 our Associate Director, Regulatory Affairs (strategist) for 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 Associate Director (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, this 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
Considerable 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.
Solid working knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the EU. A good understanding of basic regulatory requirements in emerging markets preferred. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies).
Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies
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.
Generally strong and independent skills 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.
Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership
Generally strong leader who is effective manager and is able to bring working teams together for common objectives. Able to mentor and develop skills of team members.
Experience in managing personnel a plus; experience managing relationships with CROs and/or contractors also preferred.
A strong interest in rare diseases and/or associated experience (e.g. accelerated processes) would be highly advantageous.
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.
Less than 1 Year
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