Dawn Watson Email & Phone Number

Napa, Ca, Us

•Directed regulatory strategies (registrations, compliance and complaints/vigilance management) to ensure timely approvals and maintenance of legally marketed anaphylactic, analgesic and dermal drug products, generics and innovative specialty assets under development.•Ensured adequacy of global dossiers to meet the company’s objectives through the execution of sound regulatory strategies, practices and focused interactions with global and domestic business partners and governmental agencies.

Brentford, Middlesex, Gb

•Expanded role into early and late stage drug development as a Global Regulatory Lead for therapeutic biological agents in development within the Respiratory, Immuno-inflammation, Oncology, Cardiovascular and Dermatology franchise units•Worked with internal resources and regulatory authorities to determine least burdensome product approval strategies•Accountable contact for the development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams•Ensured regulatory assessments and potential risks were communicated to allow for key decisions to be made and cascaded within the R&D organization in a timely manner•Led team of regulatory professionals to assure global regulatory alignment on projects in disease area and disease area regulatory strategy•Independently directed/ guided strategic discussions that facilitated planning and execution of global strategy supporting development in major markets (North America, Europe, Asia Pacific, China and Japan•Commented on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provided executive management with regulatory metrics/information•Communicated regulatory strategy to global project teams•Worked collaboratively across the business on content of global regulatory submissions•Developed and maintained communications with FDA/EMA and coordinated interactions and dossier preparations for use with regulatory agencies worldwide (i.e., meeting strategy, briefing documents, advisory meetings, special protocol assessment (SPA), orphan drug request, pediatric plans (PIPs/PSPs)•Led or participated in multi-departmental and multi-site teams to support timely implementation of quality strategies

•Primary FDA liaison for CMC regulatory activities (pre-IND/IND, NDA/sNDA) for NCEs and marketed products•Interfaced with global cross functional formulation development, labeling and manufacturing teams to mitigate product quality issues, to ensure reproducibility of manufacturing process, robustness of CMC specification, stability, consistency of labeling/packaging and overall registration data package.•Led regulatory teams for Pulmonary and Cardiovascular development projects as well as marketed line extensions•Guided project teams on the regulatory strategy for clinical development, FDA meetings and product registrations from clinical development through, approval, including the initial product launch and subsequent advertising/promotional campaigns•Negotiated favorable meeting outcomes with Regulators to support continued US registration efforts (i.e., pre-IND, End-of-Phase 2, pre-NDA)•Managed routine regulatory support for currently marketed products•Primary FDA site contact for PAI- related issues, GMP inspections, product recalls and site transfer activities•Supervised, and guided group on the appropriate document content for regulatory submissions (i.e. IND/NDA/labeling submissions, promotional and advertising packages)•Reviewed and approved analytical changes (i.e., process change notices)•Conducted regulatory safety review of 10-Day and 15-Day adverse event reports (AERs) prior to FDA submission•Performed regulatory re- view of clinical protocols, investigator's brochures, and clinical reports to ensure adherence to GCP requirements.

Brussels, Be

•Regulatory Liaison for Cardiovascular, Gastrointestinal and sterile medical products and devices•Coordinated INDs/NDAs/ANDAs and DMFs. •Directly interfaced with FDA reviewers•Interpreted INDs/NDAs requirements for project teams, including content of annual maintenance support activities