Sr. Regulatory Project Manager; Biotech or Pharmaceutical exp

Job Description

Sr. Regulatory Project Manager (Biotech or Pharmaceutical exp.)

The Senior Manager of Regulatory Filing Excellence will report to the Director of Global Filing Excellence and Project Management. Given clients uniquely robust late stage pipeline, a need has been identified to establish a focused capability to develop and implement best practices for preparing major global regulatory filings. This role will work closely with the Global Regulatory Lead and Regulatory Operations, as well as cross‑functional filing teams and management to facilitate timely submission of high-quality data packages to US and international health authorities.

Bachelor's degree in a scientific or medical field preferred with at least 6 years' experience in the biotechnology or pharmaceutical industry. Demonstrated project management skills with an ability to prioritize multiple projects.

Experience developing project plans, content plans and other filing to

Strong technical system proficiencies particularly Smartsheet, MS Project, Visio and Excel, Veeva, SharePoint (Think‑Cell, Milestones Professional, One Pager, or similar a plus). Excellent organizational and meeting management/facilitation skills. Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels. Excellent written and verbal communication skills, including negotiation skills.

Ability to work in a fast‑paced environment and driven to succeed. Ability to problem‑solve, identify bottlenecks, and escalat­e issues appropriately in a timely fashion. Working understanding of regulations and experience in interpretation of Health Authority guidelines.

Experience with regulatory filings, original NDA/BLA/MAA and response to questions a plus.