This cancer treatment company develops chemotherapy delivery technologies for the targeted administration of high-dose chemotherapeutic agents to specific organs or regions of the body. They will be filing their first NDA this year and are seeking a Regulatory Project Management Contractor who can assist in the project planning and maintain Gantt-charted timelines for the submission deliverables. This contract will be approximately 40 hours a week for about a year.
Responsibilities:
- Coordinate end-to-end planning and execution of assigned deliverables including Gantt Charting of project plans.
- Contribute to regulatory submission strategy, identifying submission risks and opportunities.
- Lead 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.
- Provide regulatory expertise and guidance on procedural and documentation requirements to cross-functional teams to ensure the delivery of business objectives.
- Apply regulatory expertise to guide cross-functional team members and demonstrate strategic thinking and creativity in support of development and submission programs.
- Update Gantt Charts to help prepare for cross-functional and senior management discussions and prepare slides for these presentations.
Background and Qualifications:
- A BS or MS degree in physical or life sciences required. An MBA degree, is a plus.
- A minimum of 5 years regulatory affairs project management experience in the pharmaceutical industry.
- Strong project management capabilities. Gantt Charting project plan experience a must.
- Regulatory therapeutic experience with Oncology programs highly desired.
- Drug/device combination product experience a plus.
- Excellent analytical skills and the ability to apply policies and general regulations to specific products or projects.
- Ability to work effectively on project teams.
- 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.
- Must possess strong analytical and process skills, and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc.
- Must possess strong verbal and written communication skill.
All candidates must be authorized to work in the United States. No visas or visa transfers will be possible.