Kathleen Heffernan..... Vincent Gotz..... Corporate....

Kathleen Heffernan

Summary

Over twenty years of experience in the pharmaceutical industry as a quality and regulatory affairs professional.  Proven ability to understand and interpret regulatory issues to assess the impact on corporate decisions.

Areas of expertise:

  • Developing and assessing regulatory strategies and timelines
  • IND, NDA and ANDA processes and requirements
  • Due diligence for product/company acquisitions
  • Dermatological product requirements, including cosmeceuticals  
  • Regulatory complexities regarding drug delivery systems
  • Labeling and advertising review, including websites and direct-to-consumer
Education
  • University of New Haven, New Haven, CT
    Masters, Business Administration, 1991
  • Fairfield University, Fairfield, CT
    Bachelor of Science, Chemistry, 1981

Professional Experience

2001-
Present		 ProPharmaCon, LLC
San Diego, CA
Managing Partner and Co-Founder
1992-2000 Dura Pharmaceuticals, Inc.,
San Diego, CA

Senior Director, Regulatory Affairs (March 1999 – December 2000)
Director, Regulatory Affairs (July 1996 March 1999)

Responsibilities:
  • Recommend regulatory strategies to Senior Management, assessing risk/benefit scenarios, outcomes and consequences associated with alternative courses of action.
  • Maintain close, continuing communications with relevant government personnel to enhance prospects of product approvals and contribute to a positive company image.
  • Conduct all Regulatory due diligence activities with regards to product and/or company acquisitions (with over 50 products investigated in most therapeutic areas)
Senior Manager, Regulatory Affairs (October 1993 - July 1996)

Manager, Regulatory Affairs   (March 1992 – October 1993)

Responsibilities:
  • Prepare and file all regulatory submissions.
  • Conduct GCP audits of numerous clinical investigators.
  • Review changes in the Regulatory environment and assess impact to organization.
  • Create appropriate standard operating procedures
  • Key contact for regulatory authorities and responsible for leading FDA meetings.
1986-1992 The Purdue Frederick Company,  Norwalk, CT

Manager, Drug Regulatory Affairs (November 1991 - February 1992)

Drug Regulatory Affairs Associate   (February 1986 - November 1991)

Responsibilities:
  • Coordinate and prepare all IND and NDA submissions. 
  • Organize submission of annual and periodic reports for all investigational and marketed drug products including reporting of all adverse experiences. 
  • Interface and correspond with different divisions of the Food and Drug Administration on a regular basis. 
  • Arrange submission of all clinical study documentation for investigational and marketed drug products. 
  • Assist various internal departments with compliance issues and requirements related to current FDA regulations. 
  • Provide regulatory representation at internal and FDA meetings. 
  • Draft and initiate internal Standard Operating Procedures.
1981-1986 Miles Pharmaceuticals,West Haven, CT

Regulatory Compliance Associate (June 1985 - February 1986)

Coordinate and collect regulatory documents for marketed drug products for submission to the Food and Drug Administration. 


Assistant Quality Assurance Scientist (July 1983 - June 1985)

Perform analytical testing on all consumer products in this division.  Provide assistance in training lower level technicians.

Quality Assurance Lab Technician   (July 1981 - July 1983)

Perform chemical and physical analysis on intermediate and finished products. 

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