Senior Regulatory Submissions Manager

Posted 06 May 2021
Job type Temporary
DisciplineScience Leaders & Specialists
ContactMaeve Fahey

Job description

This global pharmaceutical organisation has over 100 years expertise in developing innovative care solutions and holistic programmes. A position has arisen for a Senior Regulatory Submissions Manager to join the global Regulatory Submissions team here in Dublin. This is a 12 month contract, with fully remote working options available.

This person will help set the direction for the department going forward, manage and facilitate complex regulatory submissions and also mentor and train less experienced colleagues, to ensure deliverables across various portfolios.

The Role

Duties and responsibilities of the Senior Submissions Manager will include:

  • Acting as Project Manager of tasks related to compilation and publishing of complex 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
  • Submission Manager lead of Global Regulatory Team - Providing overview/status of submission activities relevant to the team and presenting and highlighting the dossier strategy and relevant submission intelligence/approach, risks and solutions as relevant.
  • Standardizing best practices for management of regulatory submissions to ensure consistency (e.g. defining submission process and timelines, adopting global core dossier and abbreviated dossiers concept and principles)
  • Responsible for defining and governing processes related to eCTD readiness and authoring submission documentation (in close collaboration with Regulatory System and Data Management Dept)
  • Responsible for intelligence related to eCTD readiness and GxP, Good Documentation practices
  • Responsible for end user liaison and advocacy within and outside of GRA, as required for document management

The Person

You will have skills and experience in the following:

  • BSc in a scientific discipline
  • 5+ years' experience working within a Submission Management function, managing complex global submissions with in-depth knowledge of global regulatory requirements for major markets US, EU, JP, CN, CA and RoW
  • Solid understanding of CMC, Labelling, Clinical within pre-approval and/or post-approval activities
  • Solid knowledge and experience within Submission Management and global market/HA requirements in relation to dossier management and submission processes
  • Strong communicator with solid project management and presentation skills
  • Strong drive and ability to execute according to plans as well as a flair for mentoring colleagues, and sharing new ideas

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.