Job Title: Regulatory Project Manager
Location: Remote (Due to Covid) - Onsite Flex (NYC)
Type: Min. 12 months contract w/extension or conversion possibilities.
Summary:
The Regulatory PM consultant will be responsible for the project planning of NDA submissions and clinical development projects.
Job Responsibilities:
- The consultant will be a regulatory specialist, with project management capabilities and responsible for coordinating end-to-end planning and execution of assigned deliverables.
- Will contribute to regulatory submission strategy, identifying submission risks and opportunities, while leading the project planning of simple amendments and supplements, through more complex NDA regulatory applications and managing timelines of each, through approval.
- Cross-functionally manage clinical development IND/CTA and NDA project deliverables and timelines.
- Will provide regulatory expertise and guidance on procedural and documentation requirements to cross-functional teams working flexibly within and across geographic regions, to ensure the delivery of business objectives.
- Responsible for Updating portfolio and management review Gantt Charts to help prepare for cross-functional and senior management discussions and may prepare slides for these presentations.
Requirements:
- A BS or MS degree in physical or life sciences required. An MBA, in addition to the technical degree, is a plus.
- A minimum of 5 years drug oncology regulatory affairs project management experience in the pharmaceutical industry.
- Must have direct working knowledge of Gantt Charting regulatory affairs oversight of clinical trial conduct of oncology drug clinical trials. (Gantt Charting project plans a must)
- Excellent analytical skills and the ability to apply policies and general regulations to specific products or projects.
- Must have direct working knowledge of FDA and International drug regulations.
- Experience working across multi-disciplinary levels, functions and regions is required.
- Must be team oriented, with the ability to motivate and work well with diverse cross-functional teams.
