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Assoc Dir Regulatory Affairs, Rare Diseases

Job in Zurich - Switzerland
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Company: Baxalta
Full Time position
Listed on 2019-11-02
Job specializations:
  • Pharmaceutical
    Pharmaceutical Quality Assurance
  • Management
    International Manager, Program Manager, Management Graduate
Job Description & How to Apply Below

Assoc. Dir. Regulatory Affairs, Rare Diseases (EUCAN - Europe & Canada)

Apply Now Job ID SR0041840 Date posted 10/09/2019 Location Zurich, Switzerland

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

Key Accountabilities

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.

    Position Requirements
    Less than 1 Year work experience
    Note that applications are not being accepted from your jurisdiction for this job currently via this jobsite. Candidate preferences are the decision of the Employer or Recruiting Agent, and are controlled by them alone.
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