Director, Regulatory Strategy

About the Role

The Director, Regulatory Strategy will provide leadership on global regulatory activities for the assigned products, with a focus on US regulatory affairs both pre- and post-approval. The individual will function as the regulatory lead for their assigned projects. Experience in development and clinical regulatory activities and providing regulatory leadership on the project teams in this area is required. The candidate will also directly provide or oversee pre- and post-approval submissions activities. The candidate should have a good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. A high attention to detail, ability to coordinate and prioritize assigned activities according to project goals and strong interpersonal skills, both written and verbal, are desired. The candidate must have at least 10 years of regulatory affairs experience and a higher degree (MS, PhD or PharmD).

Key responsibilities of the role:

• Provide regulatory leadership on the project teams, with a focus on development and clinical regulatory affairs, but with good knowledge of other areas of regulatory affairs.
• Work with project teams to resolve complex project issues utilizing regulatory expertise and knowledge of regulatory requirements and regula