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Regulatory Affairs Site Officer

Ref: 75567

  • 41,000-52,000
  • 07 Sep 2021
  • Waterford
  • Permanent

Regulatory Affairs Site Officer

About the Company

This is a fantastic opportunity for an experienced Regulatory Affairs Officer to join one of the leading Pharma sites in the South East. Renowned for their progressive culture and supportive environment this is an employer of choice in the region.
On offer is a 23 month fixer term contract with an attractive salary and benefits package.
To be considered you must have previous CMC experience.

About the Position

Key Responsibilities 

  • Have in-depth knowledge with regard to CMC Regulatory aspects of specific products (commercial and / or clinical).
  • You will support product evaluations / changes with regard to regulatory assessment and product transfers.
  • Collaborate with local and Global (Development, Technical, Regulatory, Operational and Quality) stakeholders with regard to New Product Introduction – clinical supply, BLA submission, etc.
  • As a member of the team you will perform troubleshooting, investigations, continuous improvements, formal and informal regulatory risk assessments.

Experience/Requirements 

  • Minimum degree in Science. Ideal – MSc or PhD in a relevant discipline.
  • 3-5 years of relevant experience.
  • Significant experience in Regulatory CMC role in the pharma or biopharma sector.
  • As this is a fixed term contract you must hold an EU passport or valid Irish work permit.

Remuneration Package

Salary is negotiable depending on experience and there is a very strong package of benefits. The role is on Days and flexible work arrangements are available.
Contact
For more information on the role or any other Engineering or Life Sciences roles call Nigel on 087 3618142 or email me or click the apply button below.