Detail

Salary
negotiable
Location
Dublin, Ireland
Posted by: Leo Pharma
17 Mar
57 Views
16 May expires

Associate Submission Manager - Global Regulatory Affairs

Dublin, Ireland
Job Description

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 at LEO Pharma A/S, 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.

 

  • 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 GRA, as required for document management

 

  • Responsible for handling deviations relating to documentation practices within the scope of GRA

 

  • Providing feedback/new ideas for improving the submission process and taking part in specific improvement activities.

 

  • Additional duties as assigned by LEO Pharma Management.

 

  • Complete all company-based and job-related training as assigned by LEO Pharma within the required timeline.
Job ID Reference
1482
Desired Skills & Experience
  • 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
Company
  New York
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have an ambitious 2025 strategy, which aims to accelerate our impact in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma´s vision is to reach 125 mill. patients worldwide by 2025. Our nimble and entrepreneurial environment allows passionate people to innovate and make a visible impact.
  Workplace
 Dublin, Ireland