Lynn has been with NDA since December 2017 and is a leading Regulatory strategist. She provides strategic guidance to clients on their drug development and regulatory submissions, globally and in a broad range of therapeutic areas.
Key Areas Of Expertise
- Extensive expertise in leading centralised submissions in the EU
- Extensive agency interactions including managing scientific advice procedures.
- Global registration filings (EU, Japan, and US)
- Clinical documentation requirements supporting European regulatory applications
- The review and writing of submission documents including orphan drug applications, IMPDs, briefing packages, CTDs for regulatory, clinical, quality sections.
- Clinical development plan scientific strategy and design
- innovative pharmaceuticals
- small molecules
- biosimilars and generics
- Strategy and content for ODD submissions
- Preparation and attendance at ODD oral explanations
- Oral Explanation (MAA)
- Preparing strategy and teams for oral explanations
- Waiver strategy and content
- Response to questions for PIPs and waivers
Lynn held senior positions at PAREXEL, Cephalon, Schwarz Parma & Hoechst Marion Roussel. Lynn has over 20 years of regulatory experience in industry and consultancy. During her career in industry Lynn has managed affiliate drug safety, medical affairs, regulatory and quality departments. In consultancy, she has led EU North operations, interim managed a multi-site team including global regulatory leads.
Lynn has a B.Sc. (Hons) Psychology with Cognitive Science