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View Cache (Job ID 13826796)
Employer Hartley People
Job Title Regulatory Affairs Team Leader
Description

The Role

  • To lead RA team in supporting regulatory issues locally at site.

  • Improve compliance and regulatory awareness.

  • To support Site RA in communication with Site, Corporate and Regulatory authorities, supporting new product and variation approvals.

  • Support & maintain regulatory filings, SMF and Manufacturing License.

  • Oversees the day to day leadership of RSOs with regard to systems and workload and training and drives efficiency / productivity initiatives to ensure effective and compliant team / systems.

  • Maintain team metrics and reports as required.

  • Support individual team member development

  • Working with Site Quality, Operations and Supply functions to ensure compliance and product supply to patients.

  • Collaborating with Global Regulatory function and gaining experience of global Regulatory practices.

  • Involvement in supporting clinical trial programs and transfer to site of new products and technologies.

  • Supporting Site and Corporate Regulatory as required.

The Person

  • Degree in Science, Pharmacy or related discipline essential.

  • Post Graduate Studies as appropriate to augment Primary Degree.

  • 3-4 years’ experience in a similar role, working with international regulatory authorities

  • Experience of Quality / Manufacturing and Regulatory operations, dealing with regulatory authorities

  • Previous team leader experience preferable.

Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent.

For immediate consideration please call Sara on 051-878813 or email your CV in response to this job posting.

Hartley People also recruit for similar roles such as Quality Control Manager, Quality Control Technician, Quality Assurance Manager, Quality Assurance Technician, New Product Development Manger, Quality Systems Manager, New Product Development Co-ordinator, Supplier Assurance Manager.

Location Waterford, Kilkenny, Tipperary
Date Added 17 days ago
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