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 deliverablesLead bid defense meetings and presentationsDevelop comprehensive pre-award site activation strategiesImplement department-wide training and coaching programsCoordinate resource projections and staffing forecastsRequirements:
Minimum twelve years global clinical pharmaceutical industry experienceAt least three years managing global teamsStrong Regulatory Affairs experience in Pharma, CMC, or PreclinicalUniversity degree or related allied health certificationFluent English and local office language;
valid passportUse global Regulatory Affairs expertise, proposal leadership, and coaching skills to advance Worldwide Clinical Trials pre-award strategy.
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