Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products
Provides regulatory expertise to Research and Development to support the design and analysis of projects
Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies
Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions
Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business
Advises cross-functional teams on regulatory aspects of product development and/or lifecycle management
Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
Writes and reviews documents with complex scientific information for regulatory submissions
Monitors project timelines and provides leadership cross functions at the level of study teams to ensure quality deliverables within defined timelines

Bachelor's Degree in related scientific discipline
12+ years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry
Knowledge and understanding of global regulations for the biotechnology and pharmaceutical industry
Understanding of global regulatory regulations
Ability to write comprehensive scientific information for use in regulatory submissions
Demonstrated project management skills
Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives

Associate Director, Regulatory

Key skills