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.