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Regulatory Affairs

  • Salary: Negotiable
  • Job type: Contract
  • Location: Waterford
  • Sector: Quality & Compliance
  • Date posted: 02/12/2016
  • Job reference: J357715A

Experis, part of the Manpower Group manage all recruitment for Sanofi Waterford. Sanofi is situated on a 37 acre site. This multi phased Biopharmaceutical facility employs over 600 personnel and is one of Irelands Great Places to work.

Regulatory Site Officer

This role is an excellent opportunity to join a leading organisation as Regulatory Site Officer in a large team working environment. This role is a 12 month temporary contract

Role Purpose:

Working as part of the RA team you will have a key role in supporting activities at an expanding manufacturing site where both oral dose and aseptic parenteral drug products are manufactured for global markets. In addition, combination products and medical devices will also be produced on site.

Accountabilities:

  • Review and evaluate the regulatory impact of proposed changes at the site.
  • Support New Product Development Projects and continuous improvement initiatives for existing products/processes
  • Provide guidance to project teams on the technical data package needed to support filings for changes to product operations (for commercial and clinical trial use) and product transfers to and from site.
  • Compilation of information for use in global filings.
  • Ensure appropriate communication of RA variation approvals, indicating when approved changes with RA impact can be implemented.
  • Compilation and maintenance of Product Specification Files
  • Maintenance of Site Master Files/Plant Master File.
  • Maintain IMB manufacturing licences and provide RA guidance into major deviations as appropriate.
  • Support Annual Report preparation as required
  • Continuous Improvement of Regulatory Affairs processes and procedures
  • Review and approval of site documentation ensuring compliance with regulatory commitments and registered product details (e.g. batch records, material specifications, protocols and reports (e.g. PQs and PVs), stability documentation, etc
  • Review and approval of artwork

Qualification:

  • 3rd Level Degree in Science, Pharmaceutical or related discipline is essential

Experience:

  • Minimum 5+ years' experience in a fast paced regulatory/compliance/quality team within a biopharmaceutical or medical device manufacturing facility required with appropriate regulatory experience.

Requirements:

  • Excellent communication skills (interpersonal, presentation & writing)
  • Ability to effectively communicate technical & non-technical information
  • Works well with others at all levels of the organization, across multi-sites, and in a multi-national environment
  • Initiative - able to work in a self-directed manner to see issues through to completion.
  • Highly motivated and has the ability to multi-task

For more information or to apply please do not hesitate to contact Dee Gillane on 051 594100 or