European Head of Regulatory Affairs

European Head of Regulatory Affairs

An exciting opportunity within a new biopharmaceutical start-up – A new global bio-pharmaceutical are in the process of setting up a  European Head Quarters in Dublin and as part of this set up they are looking to hire a senior Regulatory  Affairs professional to head up the European function in this area :

  • This positon will report into a Global SVP Regulatory Affairs and will be primarily focused on setting up the European Regulatory Affairs function in the Dublin office.
  • This position will focus on developing strategies for post marketing regulatory submissions and required maintenance for all commercial products in Europe.
  • This position will also work with the organisation’s CRO partners to manage and review all marketing material for all pipe-line products.
  • To establish and implement all SOPs for the European regulatory affairs function and assist in inspection readiness of European office.
  • Educate project teams on regulatory requirements to ensure effective product development and registration.
  • Keep up with all European legislation and guidance.

PhD, PharmD , Masters /Degree ideally in the life sciences sector and ten- 15 years plus regulatory experience within pharmaceutical or biopharma experience.

Bio-pharma start-up a distinct advantage.

The Next Step for you: 

Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on +353 1 6629120. 

Next Generation are specialists in Engineering, Data Science, Digital, Finance, IT Contract, IT Permanent, Life Sciences, Supply Chain, Procurement and Operations 

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