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Regulatory Affairs Officer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Science
  • Date posted: 26/02/2018
  • Job reference: J380134A

Our client, a major pharmaceutical company based in Waterford, are currently recruiting for a Regulatory Affairs officer to join their expanding team.

Reporting to the Senior Regulatory Affairs Officer and based at the R&D Centre on the Cork Road, the successful candidate's role will include some of the following responsibilities:

  • Dossier preparation in collaboration with the client's in-house R&D team (the R&D capacity is substantial with over 60 in the team and expanding all of the time) to support their generics portfolio. Dosage forms include high containment, tablets, capsules, soft gel capsules, dry powder inhalers and injectables. Territories are diverse and include US, EU, Japan and many ROW territories.

  • Licensing support for a portfolio of new drug developments - some are authorised and others are at various stages of clinical development with our client in their CMC Centre of Excellence and Supply Chain.

  • Working with licensing partners in US, EU and Japan for these new projects - IND support, Paediatric development and involvement in PIPs and PMRs for EU and US.

  • Biologics - a new R&D facility houses a sterile fill finish line for manufacture of one of the client's new biological products. The Regulatory team will be closely involved in dossier preparation for global registration on completion of the Clinical program.

  • Veterinary portfolio regulatory strategy - our client is developing a portfolio of new drugs for use in small animals with primary focus on US, followed by EU. Interaction with FDA and EMA on filing strategy and dossier content.

Requirements for the role:

  • You MUST be passionate about Regulatory Affairs
  • Degree in Chemistry or Pharmacy (or a related discipline)
  • Ideally you will have 1-2 years' of Regulatory experience, however other CMC focused Pharma experience considered
  • Self-starter who enjoys working in a fast-paced environment
  • You MUST enjoy working as part of a team and be fun and friendly

What's on offer:

  • An incredibly broad range of products; Generics and New Drug developments; Human and Veterinary
  • A strong clinical team in-house and a substantial R&D capacity - both of which makes the company autonomous and self-resourced to deliver projects
  • Working for a company who develop their employees and encourage them to undertake further training and courses wherever possible

For further information on this role, please contact Kathryn on 01 645 5250 or at