Sr. Manager, 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 Sr. Manager 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)
- Manage, plan, and prepare submissions for products lifecycle from a global and regional perspective
- Ensure leadership by managing operational activities for assigned deliverables, submission content plans and submission tracking
- Share best practices with applications and procedures during internal/external SME interactions during day-to-day work while in a highly dynamic environment
The Sr. Manager should have the following qualifications:
- BA/BS Degree in Science or 6+ years of related discipline
- 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
- Cultural awareness
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! 😊
