Proclinical is seeking a Senior Regulatory Portfolio Manager for a remote contract role. This role is integral to our team, partnering with Regulatory Leads and the wider Global Regulatory Sub-Team to deliver and execute optimal regulatory strategies for assigned assets. 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.
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