Lead regulatory strategy for Worldwide Clinical Trials across Europe and Canada, shaping proposals, bid defenses, and customer deliverables globally. Apply Regulatory Affairs expertise and global startup knowledge in a leadership role.
As Director, Regulatory Pre-Award Strategy, you will direct business development and pre-award activities for competitive proposal offerings. You will design regulatory strategies, oversee proposal development, approve deliverables, and build department-wide training. The role connects Regulatory, Business Development, Therapeutic Area, Project Management, and Site Management functions.
Key Responsibilities:
- Direct pre-award regulatory strategies and customer deliverables
- Lead bid defense meetings and presentations
- Develop comprehensive pre-award site activation strategies
- Implement department-wide training and coaching programs
- Coordinate resource projections and staffing forecasts
Requirements:
- Minimum twelve years global clinical pharmaceutical industry experience
- At least three years managing global teams
- Solid Regulatory Affairs experience in Pharma, CMC, or Preclinical
- University degree or related allied health certification
- Fluent English and local office language; valid passport
Use global Regulatory Affairs expertise, proposal leadership, and coaching skills to advance Worldwide Clinical Trials pre-award strategy.