Associate Director of Regulatory Affairs

This innovator is a late stage clinical biotechnology company focused on the discovery, development and commercialisation of novel protein immunotherapies, for the potential treatment of diseases that involve amyloid or cell adhesion. With 3 product candidates at various stages of clinical trials, the future of this organisation is looking bright given recent trial results. Due to continued positive trial results, this organisation are looking to recruit a new Associate Director of Quality into the business that will assist in the continued set up of the Quality organisation.

The Position:

  • 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 customisation of CTA dossiers, and organise 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 the organisation 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 organisations
  • 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 commercialisation of company products
  • Provide training on specific regulatory topics
  • Support contractor selection and coordination of contracted activities

The Person:

  • 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 commercialisation; EU registration experience required
  • Experienced with CTA submissions and maintenance as well as PIPs (Paediatric Investigational Plans)

To learn more apply online or contact Shane Browne on +353 1 632 1865.

Salary: On Application Location: Dublin South