Accomplished regulatory affairs expert providing leadership and strategic support to cross-functional teams across the product life-cycle in central nervous system (CNS), cardiovascular and hematology therapy areas. Seeking a position in regulatory affairs utilizing strong leadership, strategic thinking, and communication skills to achieve drug development and business goals.
Highlights
Organizational Leadership
Health authority Negotiation
Effective Communication
Team Building
Problem Resolution
Consensus Building
Core Accomplishments
Provided regulatory guidance for submissions of clinical trial applications (CTA) which resulted in quicker study start up globally.
Successfully negotiated with health authorities to reverse negative opinions on company's CTAs.
Oversaw the compilation, submission and successful activation of INDs.
Contributed to first cycle approvals of efficacy supplements for the addition of new indications.
Defined strategy and prepared company personnel for successful interactions with health authorities.
Managed successful labeling negotiations resulting in labels which were in line with the target product profile (TPP).
Delivered first cycle approvals of various chemistry, manufacturing and controls (CMC) and labeling supplements.
Created drug safety and medical information functions, including authoring SOPs, acquiring and validating appropriate databases, and recruiting and hiring staff.
Led the development and launch of company's website.
Professional Experience
Associate Director, Global Regulatory Affairs, 01/2012 to Current Acadia Pharmaceuticals Inc. – San Diego, CA,
Defined strategy for submission of global clinical trial applications (CTA) leading to reduced time between the start of study in the US and the rest of world.
Worked with cross-functional development team to define strategy for company responses to health authority queries and/or requests leading to timely approvals of CTAs, including successful negotiation with health authorities to reverse negative opinion on CTAs.
Responsible for delivery of eCTD Modules 1, 2 and 5 for two efficacy supplements for the addition of two new indications three months ahead of agreed upon timelines. The efficacy supplements received first cycle approvals
Oversaw US Package Insert development activities and labeling negotiations with the FDA. Labeling negotiations resulted in a final label which was in line with the Target Product Profile (TPP).
Led the pharmaceutical development team to file CMC supplements, including a prior approval supplement for the addition of a new tablet strength resulting in a first cycle approval.
Provided regulatory leadership and support for the brand teams in the review of promotional materials.
Core member of a company-wide work stream which implemented two low-cost, high impact solutions for improving the work, process and structure at Sunovion.
Associate Director, Global Regulatory Affairs, 10/2008 to 01/2012 Acadia Pharmaceuticals Inc. – Princeton, NJ,
Accountable regional regulatory partner for all US regulatory activities for early development projects and marketed products.
Defined strategy and prepared company personnel for successful interactions with FDA, including face-to-face meetings and teleconferences.
Managed the compilation, submission, and successful activation of INDs and ensured compliant maintenance of these INDs.
Effectively coordinated and defined submission strategy for NDA labeling supplements which resulted in first cycle approvals.
Led regulatory due diligence activities for potential in-licensing opportunities.
Managed the development of SOPs which contributed to a more consistent and efficient operation of the department and inter-department activities.
Supported activities for the submission of orphan drug applications.
Clinical Drug Safety - US Head, 03/2004 to 10/2008 Centerfield – Boston, MA,
Created the clinical drug safety department which achieved a 100% compliance rate for global reporting of serious adverse events.
Hired and managed the development of four pharmacovigilance professionals.
Authored global SOPs and local working practices for case management processes which led to improved quality and consistency of individual case reports.
Delivered a validated global drug safety database, ARISg .
Standardized the safety section of protocols and redefined the end of study follow-up period to be shorter by as much as 50%.
Coordinated with data management group to reconcile SAEs between the clinical and the safety databases on an ongoing basis resulting in a quicker database lock.
Authored and reviewed documents including, IND annual reports, Investigator's Brochure and clinical study reports for submission to regulatory authorities.
Led a corporate initiative to develop and launch the company’s website .
Senior Medical Affairs Associate, 08/2002 to 02/2004 Mayne Pharma (USA) Inc. – City, STATE,
Established the medical information and drug safety departments which resulted in decreased outsourcing costs by approximately 50%.
Created standard written responses to streamline response generation for incoming medical/clinical inquiries from internal and external customers.
Prepared professional product information in support of sales representative training for a new drug launch.
Authored and submitted expedited (15-day)) and periodic adverse drug experience reports (PADERs) for marketed products with a 100% compliance rate.
Assisted with the timely implementation of E2B gateway to meet compliance with EU regulations on electronic reporting of expedited reports.
Assistant Scientist, Technical Operations, 10/2001 to 08/2001 Ortho McNeil Pharmaceuticals – City, STATE,
Responsible for stability testing of clinical trial materials and updating validation SOPs for production and packaging equipment.
Associate Editor, 06/2001 to 10/2001 Scientific Therapeutics Information – City, STATE,
Responsible for preparing written scientific materials, including manuscripts for peer-reviewed journal publication and power point presentations for trade shows, for a sponsor pharmaceutical company.
Education
Doctor of Pharmacy: , Expected in 2001 University of Michigan - Ann Arbor, MI GPA:
Bachelor of Arts: Biology and English, Expected in 1995 Rutgers University - New Brunswick, NJ GPA:
Affiliations
Drug Information Association (DIA)
Regulatory Affairs Professional Society (RAPS)
American Society of Health System Pharmacists (ASHP)
Phi Delta Chi (alpha chapter) – Professional Pharmacy Fraternity
Skills
Proficient in Microsoft applications
Expert knowledge of regulations/guidelines governing development of pharmaceuticals
Excellent communication, team building, negotiation and leadership skills
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