Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are a worldwide 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.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
What the Director, Regulatory Pre-Award Strategy Does at Worldwide
Accountable for senior-level leadership in establishing the operational strategy and achieving high performance and growth objectives for general regulatory affairs. Reports to Senior Vice President, Site Activation and Regulatory Affairs. This role has project-specific dotted line reporting to the Site Activation Therapeutic Leads.
What You Will Do
Oversees the delivery and performance of regulatory affairs activities and supporting roles such as Regulatory Affairs Managers and Regulatory Affairs Specialists.
Provides expert regulatory advice and contributes to regulatory project work for internal and external customers.
Provides and drives the overall planning and oversight for regulatory affairs activities including high quality and timely delivery for internal and external stakeholders and projects.
Responsible for regulatory affairs-related in business development activities by attending key Proposal Strategy Meetings (e.g., Executive and Strategic level), contributing to proposals and bid defense meetings by preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets, contracting process, essential document activities and other country and/or project-specific activities for regulatory affairs in support of the overall site activation strategy.