Regulatory Asset Oversight Manager
5 days ago
We are seeking an experienced and ambitious Regulatory Asset Oversight Manager to join our team at Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma, and IT. This is an exceptional opportunity to drive change and transformation efforts that enable successful regulatory outcomes for our clients.
The ideal candidate will have a strong background in drug development and manufacturing, with extensive knowledge of worldwide regulatory requirements. You will be responsible for managing multiple projects simultaneously, providing assessments and conclusions/action plans within and across departments, and identifying risks associated with submission data and information packages.
This role offers the chance to lead key activities to progress your career and contribute to our mission to unite science, technology, and talent to get ahead of disease together.
About the RoleAs a Regulatory Asset Oversight Manager, you will:
- Develop and maintain a holistic view of the global regulatory integrated plan at the asset level for operationalizing the Global Regulatory Strategy and supporting the GRL in ensuring appropriate resource is engaged to deliver to the plan.
- Drive the execution of the agreed plans to ensure teams are on-track to deliver per the Global Regulatory Strategy (GRS), performing scenario planning, impact analyses, critical path analyses, and facilitate risk mitigation in response to any issues/risks that arise.
- Leverage expertise to assist RMTs and GRLs with submission delivery strategies that align with R&D objectives, e.g., Hyper-Acceleration, Acceleration in regions.
You will also employ a structured approach with assigned RMTs to ensure that the submission delivery strategy is aligned with the Global Submission Strategy (GSS) throughout the late-stage Development lifecycle.
About UsLifelancer is a dynamic and innovative company that connects talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. We are committed to creating a culture of innovation, performance, and trust.
What We OfferWe offer a competitive salary of $120,000 - $180,000 per annum, depending on experience, plus additional benefits including:
- A comprehensive benefits package.
- Professional development opportunities.
- A collaborative and supportive work environment.
Join us in this exciting opportunity to make a difference in the lives of millions of people and advance your career as a Regulatory Asset Oversight Manager.
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