Associate Submission Manager

Location
Dublin (City), Leinster (IE)
Salary
Negotiable
Posted
05 May 2021
Closes
04 Jun 2021
Ref
O-2103-464997
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

On behalf of my client, we are working with them for a new role of Associate Submission Manager within the Regulatory Affairs Submission Management Department. This role will directly report to the Head of Regulatory Submission Management. This role does not have any direct reports.

As a key member of the team, your role will be to help manage and facilitate global regulatory submissions to ensure deliverables for a given portfolio. You will join a team of dedicated and skilled submission mangers responsible for ensuring compliant and timely global submissions across all portfolios.

The primary tasks of the role include (but are not limited to):

This position is overall accountable and responsible for project managing compilation and publishing of global submissions, as well as supporting the overview of all submissions to ensure deliverables across a given portfolio.

As a Submission Manager in Global Regulatory Affairs, your responsibilities include:

  • Act as Project Manager of tasks related to compilation and publishing of simple global Regulatory submission.
  • Creating and managing cross-functional timelines for global submissions with consideration of key interdependencies
  • Leading a global (external) publishing team in the context of a given submission
  • Managing the timely delivery of compliant global submissions
  • Responsible for technical interactions with global HA, i.e., gateways, validation issues and similar
  • Support to Submission Manager lead of Global Regulatory Team – Giving input to overview/status of submission activities under the guidance of senior colleagues as required.

The ideal candidate will possess the following:

  • BA/BSc Degree in scientific discipline required; Master’s Degree preferred
  • Previous experience working in global regulatory affairs is not a requirement but an intertest in the area is essential and some knowledge would be beneficial.
  • Awareness of pre-approval and post-approval activities
  • Awareness of global HA requirements in relation to dossier management and submission processes
  • Interest in project management, strong communication and presentation skills as well as good ability to plan and prioritize; strong drive and ability to execute according to plan, good collaborator.
  • Time and quality focused when executing on submissions; focused on KPIs and deadline driven.
  • Knowledge and experience interacting with different people (e.g., Local RA, publishing team etc.) also with the understanding of cultural differences and perspectives.
  • The ability and willingness to travel internationally (mainly Europe) approximately 10-15%
  • Must be able to perform all essential functions of the position, with or without reasonable accommodation.

For full details contact tdunne@thornshaw.com or call Tina at +353 1 2784701 or 087 6811990

Thornshaw Scientific is a division of the CPL group.  www.thornshaw.com