• Associate Director, Regulatory Affairs (EU)

    Job Locations IE-Dun Laoghaire
    Job ID
    Research & Development
  • Overview

    Reporting to the Director of Regulatory Affairs, and in accordance with the goals of the company, and applicable regulations, standards, established procedures and planned objectives, the Associate Director of Regulatory Affairs will be responsible for developing regulatory strategies, and planning, managing and executing regulatory activities for investigational drug products in the EU & RoW.


    • Develop EU regulatory strategies and work with the Director of Regulatory Affairs and global Regulatory team towards the development of global regulatory strategies
    • Provide strategic input to the global Regulatory team for all EU-based Regulatory Affairs matters including the seeking of Scientific Advice
    • Define and execute strategies for regulatory submissions for CTAs/MAA and required maintenance (amendments, notifications, variations, renewals, annual updates) for drug products in the EU; as needed, work with regulatory affairs consultants/contractors, submit regulatory documentation and act as primary contact with the EMA and EU National Competent Authorities (NCAs) as needed
    • Manage customization of CTA dossiers, and organize submission and registration of drug products in a professional, compliant and timely manner
    • Support the writing and review of SOPs and assist in inspection readiness programs
    • Serve as a representative of Prothena to the EU regulatory community; serve as a liaison with the EMA and NCAs to support effective professional and company relationships
    • Educate project teams on regulatory pathways and requirements to ensure effective product development and registration
    • Maintain an effective archiving system
    • Ensure that the pharmaceutical products distributed in the EU meet EMA/ICH/NCA requirements and support the local commercial organizations
    • In partnership with other regulatory staff, maintain and expand current knowledge of regional regulatory requirements and precedents (e.g. new regulations and laws) that may affect the clinical development and commercialization of company products
    • Provide training on specific regulatory topics
    • Support contractor selection and coordination of contracted activities
    • Performs all other duties as required


    • PharmD, PhD, Masters or Bachelors degree, preferably in life sciences
    • Minimum of 7-10 years of Regulatory experience, with at least 3-5 years in in a similar EU-based leadership role
    • Ability to oversee regulatory activities and manage process from research/discovery, clinical development through to commercialization; EU registration experience required
    • Experienced with CTA submissions and maintenance as well as PIPs (Paediatric Investigational Plans)
    • Knowledge of EU procedures (fast to market procedures would be an advantage)
    • Post marketing/ life-cycle management experience (Variations, Renewals and Labelling) preferred
    • Familiarity with FDA IND/NDA/BLA regulatory process preferred
    • Regulatory project management experience
    • Ability to build/forge relationships with key parties (e.g., NCA)

    Competencies and Attributes:

    • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and core values – courageousness, imaginative, selflessness and joyful
    • Must possess excellent interpersonal skills
    • Must have the ability to build and maintain positive relationships with management, peers, and direct reports
    • Ability to build/forge relationships with key parties (e.g., Competent Authorities, Vendors)
    • Excellent written and verbal skills required. Must display strong analytical and problem solving skills. Attention to detail essential.

    Travel requirements:

    • Up to 20 % travel required: U.S. and Europe



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