Regulatory Affairs Specialist

  • Cork
  • Temporary 12 months
  • JO-1909-64732_1567507519

Summary

Responsibilities

  • Preparation and submission of new product applications.
  • Preparation and submission of CMC and administrative variations.
  • Preparation and submission of safety variations.
  • Preparation and submission of renewals.
  • Preparation and submission of change of ownership applications.
  • Preparation and submission of Article 61(3) applications.
  • Regulatory support for IE markets.
  • Preparation and submission of sunset clause applications.
  • Communication of regulatory approvals to interested parties.
  • Maintenance of PA registered details
  • Maintenance of standard operating procedures.
  • Timely archiving of regulatory documentation.
  • Training internal and external

Competencies

  • Dealing with ambiguity: Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty.
  • Peer relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.
  • Action-oriented: Enjoys working hard; is action-oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.
  • Drive for results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.

Requirements

  • Relevant experience in new product, variation, and other regulatory submissions.
  • Good understanding of relevant IE legislation.
  • Excellent communication and interpersonal skills.
  • A proactive approach to problem-solving.
  • Good time management skills.
  • Flexibility in line with changing priorities.
  • Meticulous attention to detail.
  • Experience of software packages such as Word, Excel, and Outlook.
  • Experience in Pharmaceutical operations arena or community/primary healthcare.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

By using this website, you consent to the use of cookies in accordance with the privacy policy Ok, got it