Regulatory Affairs Submission Specialist

14 Jun 2019

Are you experienced with Regulatory Submissions?

A great opportunity has opened for a Regulatory Submissions Manager to join a global pharmaceutical company. This is a permanent role and is based in Dublin.

In this role you will be responsible to plan, manage and facilitate the delivery of submissions within a given product/portfolio

Key Responsibilities include:

  • Preparation of the Regulatory Submission Pipeline;
  • Ensuring the creation and project management of Regulatory Submission Plan for individual submissions;
  • Providing advice on submission approach and HA requirements as well as ePublishing requirements to relevant project members and content owners;
  • Preparation, review, coordination and follow up (depending on submission type) to secure relevant documents and submission components for the dossier;
  • Ensuring proactive follow up on submission status/approval timelines making sure progress is managed till HA approval and case closure;
  • Communicate key milestones to relevant stakeholders;
  • Providing feedback/new ideas for improving the submission process and the sourcing set-up and take part in specific improvement activities;
  • Providing support/guidance to sourcing partner giving advice and answering questions on specific tasks within the Regulatory Submission Pipeline, as needed;
  • Representing Submission Management in the Regulatory focus teams within a given portfolio/product - Providing overview/status of submission activities relevant to the team and presenting and highlighting the submission strategy and relevant submission intelligence/approach, risks and solutions when needed.

What you'll need to succeed:

  • 5 - 7 years of experience working within Regulatory Affairs and within one of the following areas (CMC, Labelling, Clinical, Submission Management, Local RA or similar);
  • Experience and knowledge within Submission management and the different market/HA requirements in relation to dossier and submission process;
  • Experience and understanding of CMC, Labelling, Clinical within pre-approval and/or post-approval activities
  • Strong and solid project manager skills and strong ability to manage a submission pipeline, keep the overview and prioritise
  • Timely, fast and quality focused when executing submissions;
  • Knowledge and experience interacting with different stakeholders with the understanding of cultural differences.
  • Degree in a Science related discipline

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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