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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Regulatory Affairs Manager


Reference:SCAMPR-604877 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs Executive, Regulatory Affairs Manager, Regulatory Affairs Officer, Regulatory Affairs Specialist

Regulatory Affairs Manager
Our client, a pharma organisation, are currently recruiting for a Regulatory Affairs Manager to join their team on a permanent basis with hybrid working. Experience working with oral solid dosage (OSD) forms is essential for this role. You will work with a small team in Ireland and other team members across the UK and EU.

Responsibilities

  • Advise and liaise services on behalf of company to ensure that requirements of national competent authorities are met
  • Create, assemble, review and publish regulatory submissions in accordance with agreed objectives and timelines and in compliance with regulatory guidelines/regulations
  • Liaise with professional members of the appropriate authority secretariats and with other companies when licensing negotiations involve submission to a regulatory authority
  • Advise managers on legislative procedures, likelihood of licence application success, etc
  • Coordinate company’s documentation practices to promote efficient compliance with regulatory requirements; to advise on data management
  • Day-to-day management of the regulatory affairs staff
  • Devise business procedures for the submissions team
  • Remain up to date on all applicable regulatory matters
Requirements
  • Scientific degree is essential
  • Will have had significant experience in the pharmaceutical industry or CRO
  • Experience of working with EMA and national competent authorities
  • Excellent communication skills for liaising and communication with contractual partners and internal departments
  • Experience and knowledge of GxP
  • Proven ability to evaluate and implement efficient regulatory strategies
  • Highly motivated and self-directed, capable of multitasking and able to work with minimum supervision
  • Mentoring and training on Regulatory Affairs activities
  • Contractual GxP oversight

For more information please contact Sinéad Cullen on +353879500821 or [email protected]