Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • Home: (555) 432-1000
  • Cell:
Executive Profile

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.

  • 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
CenterfieldBoston, 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 PharmaceuticalsCity, 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 InformationCity, 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.

Doctor of Pharmacy: , Expected in 2001
University of Michigan - Ann Arbor, MI

Bachelor of Arts: Biology and English, Expected in 1995
Rutgers University - New Brunswick, NJ

Drug Information Association (DIA)

Regulatory Affairs Professional Society (RAPS)

American Society of Health System Pharmacists (ASHP)

Phi Delta Chi (alpha chapter) – Professional Pharmacy Fraternity

  • Proficient in Microsoft applications
  • Expert knowledge of regulations/guidelines governing development of pharmaceuticals
  • Excellent communication, team building, negotiation and leadership skills
  • Experienced in computerized system validation

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School Attended

  • University of Michigan
  • Rutgers University

Job Titles Held:

  • Associate Director, Global Regulatory Affairs
  • Associate Director, Global Regulatory Affairs
  • Clinical Drug Safety - US Head
  • Senior Medical Affairs Associate
  • Assistant Scientist, Technical Operations
  • Associate Editor


  • Doctor of Pharmacy
  • Bachelor of Arts

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