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Regulatory Project Manager

  1. UK
2024-111683
  1. ICON Strategic Solutions
  2. Regulatory Affairs
  3. Remote

About the role

Regulatory Project Manager - UK/ Europe - Homebased

 

In partnership with the Regulatory Leads, the RPM drives submission projects forward through the translation of regulatory strategy to executable plans and coordination of cross-functional team efforts. The RPM utilizes in-depth knowledge of regulatory submission requirements, eCTD structure and associated planning software to create and maintain a detailed integrated Submission Plan that captures the list of dossier content, key activities, and timelines.

 


What you will be doing:

  • The RPM partners with PM and Regulatory Leads as applicable and consults other Submission Team members to create an integrated and dynamic operational regulatory submission plan in support of projected global regulatory approval for assigned asset(s) in targeted regions, and therapeutic indications and/or presentations per corporate strategy;
  • Scenario planning taking into account all submission activities that rely on resources needed for assigned submission plans;
  • Creates visuals, reports to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders; anticipates delays and mitigates impact to timelines ;
  • Ensures submission team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the interdependencies between submission activities and meets target submission dates;
  • Enables function leads to ensure that all documents are prepared with global Regulatory/ Health Authority quality standards;
  • Leads submission planning discussions incl., setting agendas, minutes and follow up on key actions with stakeholders;
  • Works with functional teams to identify ways to optimize and accelerate submission timelines;
  • Partners with PMs to ensure submission project plan and cross-functional project plans are aligned and optimized;

You will have:

  • Program Management experience within a regulated Pharmaceutical or Biotech environment;
  • Creating and maintaining Global submission plans to be compliant with regulatory timelines and capturing eCTD content and associated activities;
  • Pharma R&D;
  • Drug development project management using MSP; experience with One-pager Pro, Planisware and PowerBI is a plus;
  • Experience in development of biologicals and rare diseases.


Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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The Role of Regulatory Affairs in Clinical Research

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Industry

Content type

Blogs

Publish date

01/18/2024

Summary

Introduction to Regulatory Affairs in Clinical Research Regulatory affairs play a pivotal role in ensuring the safety, efficacy, and quality of pharmaceutical products and medical devices. In the

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Explore the pivotal role of regulatory affairs in clinical research with our insightful blog.

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