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Senior Regulatory Affairs Officer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Science
  • Date posted: 26/02/2018
  • Job reference: J380135A

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Our client, a leading pharmaceuticals company in Waterford, are currently recruiting a Senior Regulatory Affairs Officer to join their R&D team. The position will report through to the Regulatory Affairs Manager and is based at the company's R&D Centre.

Responsibilities of the role will include the supervision, coaching and training of a number of Regulatory Affairs Officers in the Regulatory Team.

The successful candidate will be responsible for a number of key projects, with the following as examples:

o Dossier preparation in collaboration with our 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 the clients 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.

o Licensing support for the portfolio's new drug developments - some are authorised (one with an NDA in the US) and others are at various stages of clinical development with the 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.

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

o Veterinary portfolio regulatory strategy - the 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 of the role:

* You must be passionate about Regulatory Affairs
* A degree in Chemistry or Pharmacy (or a related discipline)
* You MUST have at least 3+ years' Regulatory experience but ideally 5 - 8 years desired
* Enjoy the coordination of tasks and management of workloads
* Self-starter who enjoys working in a fast paced environment
* You must enjoy working as part of a team and be fun and friendly

If you are interested in discussing this role or similar roles further, please contact Kathryn Whyte on 01 645 5250.

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