It is built by those who take pioneering, creative approaches and implement them with quality and excellence. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

What The Regulatory

Pre-award Strategy Director Does At WorldwideThis is a leadership role, accountable for directing business development and pre-award activities, developing them into compelling and competitive proposal offerings leading to bid defenses. Pre-award activities include designing and driving regulatory strategies, overseeing proposal development and approving pre-award deliverables. The role also requires designing and implementing a department-wide business development training and coaching program for various roles within the department.

Have and apply knowledge of global start-up and regulatory activities to pre-award customer deliverables, resulting in a differentiated advantage for bid defense and award Collaborate with Regulatory team leadership, Therapeutic Area leadership, Business Development, Project Management, Site Management and other functions to develop comprehensive pre-award site activation strategies Develop and implement a comprehensive department-wide training and coaching program in collaboration with internal stakeholders Achieve operational and financial performance targets related to proposal budgets and strategies Proactively interact cross-organizationally to develop and learn about emerging business, regulatory,



therapeutic, and operational strategies that improve service to our internal and external customers Instill confidence in our customers during the proposal and bid process through knowledgeable and accurate communication of our startup strategy, including global / country regulatory requirements May help develop and implement cross-functional initiatives for continuous process and quality improvements Demonstrated strong ability to define, organize, and develop complex Regulatory Affairs strategies into effective customer deliverables Demonstrated strong experience in effectively persuading internal and external customers and engaging in difficult conversations with desired results Strong experience in Regulatory Affairs is required, and experience with at least one cross-functional department, such as Regulatory Compliance, Feasibility, Site Management, Project Management, or Patient Recruitment, is preferred Interest and adaptability to drive innovative solutions for our customers, such as with decentralized clinical trials, remote and local home healthcare models, and direct-to-patient technologies Aptitude or proficiency in using and learning digital and software systems nursing certification, medical or laboratory, or laboratory technology)



or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities Minimum of twelve (12) years of global clinical pharmaceutical industry experience, including 3 years of demonstrated skills and competency in managing teams in a global environment Experience in Regulatory Affairs in Pharma, CMC and/or Preclinical (Toxicology) knowledge Experience in Scientific advisory support & briefing packages prep Deep knowledge of the US & Global regulatory landscape is a plus Available for domestic and international travel, including overnight stays Valid passport Fluent in local office language and in English, both written and verbal To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.

We know that when our employees feel appreciated and included, they can be more creative, creative, and successful. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. #

📌 Director, Regulatory Pre-Award Strategy - Europe/Canada- Remote (Winnipeg)
🏢 Worldwide Clinical Trials
📍 Winnipeg