Medical Development
Resume:
DAWN WATSON
Cary NC *****
*******@*******.***
EDUCATIONAL BACKGROUND
Long Island University, A&M Schwartz College of Pharmacy
B.Sc. Pharmacy, June 1986
Registered Pharmacist, NJ State Board Certified, June 1987
RESEARCH AND PROFESSIONAL EXPERIENCE:
IVueLink Consulting.,
Vice President and Pharmaceutical Regulatory Consultant
August 2014 to present
• Effectively manages and implements global regulatory strategies to support
the registration of client’s drug development portfolios.
• Establishes risk management planning, deepens and sustains key
relationships across the business including interactions as may be required
with internal stakeholders (e.g., R&D, Medical, Quality, Commercial) to
support internal preparation for regulatory interactions with health authorities
including meeting management.
• Manages preparation of global regulatory documentation (e.g., meeting
requests, briefing packages, response to agency queries, advisory committee
preparation, etc
• Oversees key submission activities including support for scientific advice and
protocol assistance to help meet the business needs and to be able to
successfully deliver on key project milestone targets.
Mylan Inc.
Vice President Global Regulatory Affairs, Mylan Specialty Pharmaceuticals
and Dermal Products
January 2014 to August 2014
• 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 for the
treatment of respiratory disorders.
• Ensured adequacy of dossiers to meet the company’s objectives through the
execution of sound regulatory strategies, practices and focused interactions
with business partners and global governmental agencies.
GLAXOSMITHKLINE
Director, Global Regulatory Affairs
October 2008 to January 2014
• 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
GLAXOSMITHKLINE
Director, US Regulatory Affairs Respiratory Products
June 2001 to October 2008
• Led the decision making process for strategic issues on cross functional
teams and due diligence in-licensing or joint ventures
• Collaborated in a matrix environment to define the content for agency
meetings (Pre-IND, EOP2, pre-NDA, Advisory Committee, etc), major
submissions/ supplements, and routine reporting of annual updates
(IND/NDA/PSURs)
• Primary contact for product matrix teams (LABA, beta-2 agonist, PDE4s)
• Interpreted regulations and strategically guided development team on
content for original NDAs, efficacy supplements, product labeling
(Prescribing information, patient leaflets), and risk evaluation and
mitigation strategies (medication guide, communication and/or educational
plans)
• Reviewed/approved professional and consumer re- lated advertising and
promotional materials (DTCA- TV Ads, mailers, print-ads, sales brochures
and training materials, brief summaries and publications) to support
adherence and compliance with DDMAC expectations for stated product
claims.
GLAXOSMITHKLINE
Product Director, CMC Regulatory Affairs
December 1997 to June 2001
• 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.
BOEHRINGER INGELHEIM INC.,
Manager, Drug Regulatory Affairs
June 1994 to December 1997
• 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.
SOLVAY PHARMACEUTICALS, INC.,
Senior Regulatory Coordinator
March 1990 to June 1994
• 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.
ALLERGAN OPTICAL, INC.,
Coordinator, Regulatory Affairs
January 1988 to 1990
• Led team of regulatory professionals to assure successful planning and
completion of regulatory activities on a worldwide basis
• Established and interpreted functional standards necessary for regulatory
reporting and submissions for contact lens manufacture
• Participated in the development and approval of labels and labeling for the
substantiation of claims and compliance with current approvals
• Conducted internal/external GLP audits
• Prepared regulatory dossiers (PMAs, 510Ks and IDEs)
• Acquired extensive medical devices/medical products experience
including a wide breadth of knowledge of registration requirements for
Class I, Class II and Class III medical devices
• Compiled research release documents to support initial product launches
and final regulatory approval of advertising and promotional activities
ALLERGAN OPTICAL, INC.,
Clinical Research Associate
June 1987 to January 1988
• Monitored, analyzed and performed clinical data and study management
for ongoing, completed or terminated ocular studies
• Assisted the Medical team with the timely case reporting of information
• Evaluated the regulatory significance of clinical results and the impact of
such data on FDA review and approval as applicable
• Developed case report forms, study protocols and SOPs
• Participated in the selection process of appropriate field study
investigators
• Tracked study progress via routine site visits and generated monthly
summaries of findings for internal use and decision making
SCIENTIFIC AND PROFESSIONAL ORGANIZATIONS:
• Drug Information Association (DIA)
• Regulatory Affairs Professional Society (RAPS)
• American Pharmaceutical Association (APhA)
• North Carolina Regulatory Affairs Forum (NCRAF)
Contact this candidate