Associate Director, Regulatory Project Manager
Summary: A leading well-known life sciences company specialized in new transformative medicine for patients. This company develops products to meet the patient needs in a safe and efficient way, having developed therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases.
The Associate Director will be responsible for:
- Working with cross functional teams to track and manage deliverables needed for regulatory submissions, including INDs/CTAs, BLAs/MAAs (Modules 1-5)
- Ensure project execution and overall regulatory project timelines are aligned
- Manage, plan, and prepare submissions for products lifecycle from a global and regional perspective to drive project execution
- Working cross-functionally with the Regulatory strategy and operational teams in the clinical, non-clinical and quality space
- Ensure leadership by managing operational activities for assigned deliverables, submission content plans and submission tracking
The Associate Director should have the following qualifications:
- BS Degree in a scientific field or 8+ years of regulatory experience
- Project management experience supporting early and late-stage submissions
- Strong submission project management skills and knowledge of drug development
- Management of regulatory submission deliverables at the project level
- Ability to work independently and with cross-functional teams
Benefits:
- Paid Sick Leave, Vacation Leave, and Floating Holidays
- 401k (traditional and Roth offered) with 50% match on first 6% deferred
- Highly competitive healthcare coverage including, Health, Dental and Vision
- Free parking, monthly subway pass or a subsidized commuter rail pass
If you, or anyone in your network, is interested in this Senior Manager Regulatory Project Manager position, please do not hesitate to apply! ๐
