Brian Mayhew

**** ********* **.

APT ***

Rockville, MD 20852

202-***-****

Summary of Qualifications

. Accomplished individual contributor and leader of multi-disciplinary

science and technology teams.

. Demonstrated expertise in managing global regulatory policy and

intelligence functions.

. Proven track record in advancing corporate regulatory policy/strategy and

public policy positions.

. Demonstrated ability to gather and assess intelligence regarding the

biopharmaceutical and medical device industry.

. Expertise in legislation and regulation pertaining to the healthcare

industry, notably laws and regulations pertaining to the Food and Drug

Administration (e.g., Food, Drug, and Cosmetic Act, FDA Amendments Act,

PDUFA, and BPCA/PREA).

. Skilled in fast-paced and diverse work environments.

Work Experience

Sr. Regulatory Policy Analyst, Merck & Co., Inc.(March, 2004-Present)

. Develop policy positions regarding regulatory and product development

issues in response to federal regulations, guidance documents, and

legislation.

. Advise senior management regarding medical and regulatory policy

initiatives.

. Manage and lead multi-disciplinary teams to provide strategic direction

on policy initiatives.

. Monitor and analyze policy changes and intelligence regarding the drug

development landscape, healthcare industry, and regulatory environment to

determine impact on Merck's business objectives.

. Communicate and leverage intelligence to internal staff regarding

regulatory and policy issues.

. Act as Merck representative to government agencies, health organizations,

and trade associations.

Director, Technology and Regulatory Affairs, AdvaMed (February, 2003 -

October, 2003)

. Developed regulatory solutions to technical and regulatory issues

impacting the medical device industry, including postmarket issues,

health IT, and other product development issues.

. Monitored and analyzed federal and state regulations, legislation, and

policy issues that affected the medical device industry.

. Managed committees, task forces, and working groups to direct the

development and communication of organization positions on key technical

and regulatory issues.

Policy Analyst, Food and Drug Administration (September, 2000 - February,

2003)

. As part of the FDA Commissioner's Policy Department, monitored and

analyzed external policy to determine changes regarding the drug

development landscape, healthcare industry, and regulatory environment to

determine impact on Merck's regulatory and business objectives.

. Staffed working groups and committees to develop FDA policy on a variety

of healthcare issues.

. Monitored priority issues to ensure the issuance of a timely response to

external stakeholders.

Senior Data Analyst, Battelle Memorial Institute (September, 1999 -

September, 2000)

. Staffed Food and Drug Administration Office of Tobacco Programs contract

for Battelle.

. Conducted research and analysis for government agencies with regard to

anti-tobacco/smoking campaigns.

. Acted as a liaison between state officials and federal program officers

on specific Agency projects.

. Filed complaints on behalf of the Food and Drug Administration against

local vendors in violation of the FDA anti-tobacco program.

Education

. Masters in Business Administration, University of Maryland, College Park

. Bachelor Degree (BA), Government and Politics, University of Maryland,

College Park

Trade Association Engagement and Professional Memberships

. Biotechnology Industry Association

- Regulatory Environment Staff Working Group

- Regulatory Affairs Committee

- FDAAA Implementation Committee

- PDUFA V Steering Committee

- Biosimilars Implementation Committee

. Drug Information Association

- Regulatory Intelligence Working Group (Vice Chair)

- Regulatory Committee Core Group

. Regulatory Affairs Professional Society

. Food and Drug Law Institute

. Food and Drug Administration Alumni Association

. Pharmaceutical Research and Manufacturers of America

- Biologics and Biotechnology Committee

- Pediatric Technical Committee

- Pharmacovigilance Working Group

- Regulatory Affairs Coordinating Committee Staff Work Group

. University of Maryland Alumni Association

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