Senior Regulatory Portfolio Manager (Remote)

This role is remote by design, with a two-step interview process conducted via Teams.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Co-lead Global Regulatory Sub-Team meetings to ensure high-quality discussions and decisions.
• Develop and maintain the asset's global regulatory book of work and Global Submission Plan.
• Track key regulatory milestones, liaise cross-functionally to generate periodic internal milestone reports.
• Provide operational support on strategic global regulatory documents including the Regulatory Strategy Plan.
• Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally.
• Represent the Global Regulatory Lead in team as needed.
• Co-ordinate preparation of regulatory components for US submissions and support preparations for FDA meetings.
• Lead or represent RPM on GRS and enterprise process initiatives to drive a culture of continuous improvement and operational excellence.

Key Skills and Requirements:

• Degree or equivalent in a healthcare-related field.
• Direct regulatory experience with developing knowledge of US and/or EU procedures.
• Ability to work independently and at pace in a global matrix environment and effectively prioritize.
• Strong sense of personal accountability for delivery; able to lead through influence and building alignment with stakeholders to deliver projects to plan.
• Continuous improvement mindset.
• Strategic problem solver.
• Good communication and negotiation skills.
• Good interpersonal skills.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at x@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.