DAWN WATSON

Cary NC *****

919-***-****

acgwdj@r.postjobfree.com

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)

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