17 days ago
Associate Director/Director, Project Management (Regulatory)
San Francisco, CA
Full time Permanent
A Clinical Stage Biopharmaceutical company in the San Francisco Bay Area is looking to hire a new Associate Director or Director, Project Manager of Regulatory Affairs to join their extensive regulatory team to help in the approvals of drugs for treatment of cancer, autoimmune disease and chronic pain. This is an excellent opportunity to join a company before they file a BLA for their lead Oncology product in Q3 2021.
This position will be responsible for providing Project Management expertise and support to projects to ensure all project milestones and deliverables are met, and that activities are well executed and managed. This particular role will be primarily allocated to supporting the Global Filing Team (GFT) for the Biologics License Application (BLA)/Market Authorization Application (MAA), and may also include project management of clinical trials and other key cross-functional activities.
- Creates and drives timelines to keep project(s) on schedule.
- Develops agenda for team meetings, helps facilitate meetings and keep them on track, and responsible for meeting minutes.
- Identify and resolve project team challenges
- Define program-related budget assumptions for annual operating plan.
- Directs the decision making process within the team by suggesting and implementing alternatives to meet changing program goals
- Reviews project plans to accommodate changes in technical, marketing, or business objectives and communicates changes accordingly.
- BA/BS in a scientific discipline is require, advanced degree (PharmD, PhD, MS, MBA, MD) preferred
- A minimum of 8 years experience in the Pharmaceutical, Medical Products or other related industry is required
- A minimum of 6 years management experience is preferred.
- Prior experience in managingl pharmaceutical or medical device product development teams is required.
- BLA/NDA/MAA readiness experience required