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Associate Regulatory Submission Manager

Location: Dublin South, Dublin
Salary: Negotiable
Posted: about 2 months ago
Role type: Permanent
Industry: Life Sciences & Engineering Practice, Science Leaders & Specialists
Contact name: Maeve Fahey
Contact email: maeve.fahey@hrmrecruit.com

Job description

This global pharmaceutical organisation has over 100 years expertise in developing innovative care solutions and holistic programmes. A position has arisen for an Associate Submission Manager - Global Regulatory Affairs to join the global Regulatory Submissions team here in Dublin. This is a permanent opportunity, with some remote working options.

This person will join a team of dedicated and skilled submission managers responsible for ensuring compliant and timely global submissions across all portfolios.

The Role

Duties and responsibilities of the Associate Submission Manager - Global Regulatory Affairs will 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
  • Report to Submission Manager lead of Global Regulatory Team - Giving input to overview/status of submission activities under the guidance of senior colleagues as required
  • Support 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 ensuring processes related to eCTD readiness and authoring submission documentation are adhered to (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 global regulatory affairs, as required for document management
  • Responsible for handling deviations relating to documentation practices within the scope of global regulatory affairs
  • Providing feedback/new ideas for improving the submission process and taking part in specific improvement activities

The Person

You will have skills and experience in the following:

  • BA/BSc Degree in a scientific discipline
  • Previous experience working in global regulatory affairs would be beneficial
  • Awareness of pre-approval and post-approval activities
  • Awareness of global Health Authority 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

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

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Maeve Fahey

Science Recruitment Consultant

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