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Lisa Girolametti

Ridgefield, CT 06877
203-448-0188 www.linkedin.com/in/lisagirolametti


Highly experienced pharmaceutical submissions and electronic filing professional leader in Regulatory and
Quality Assurance. Solid working knowledge and experience with FDA/ICH guidelines for electronic publishing,
filing and archiving of IND/NDA/BLA/DMF submissions in CTD/eCTD format. Perfect record of on-time major
filings of original IND and NDAs. Extensive experience in creating solutions for complex projects and
technology integration. Proven expertise in budget preparation, operational performance measurement and staff
motivation. Strengths include client focus and product quality.



Associate Director, Global Submission Services, Regulatory Affairs Operations 2009 - 2016
Managed and developed ten full-time employees and three external consultancy staff. Provided leadership for
~4000 submissions in compliance with Corporate and local SOPs and FDA Regulations. Recognized for extreme
accuracy and talent development. Provided regulatory expertise to Regulatory Affairs, Information Technology
and Clinical Operations.
- Led the on boarding of external outsourcing partners for publishing, submission compilation and archiving
services. Authored Scope of Work, Service Level Agreements, Key Performance Indicators and contracts.
Managed budget, ensured timely training and technical support and evaluated teams performance.
- Provided direction to project teams and cross functional teams with the implementation of electronic
initiatives; Subject Matter Expert on submission strategy on behalf of Global Submission Services.
- Led the implementation of electronic submission systems and business processes which included the
transition from paper to eCTD format.
- Improved business processes for timely and more efficient delivery of submission documents to Regulatory
Affairs; by overseeing, provided guidance and implemented the IND Investigator Project, standardizing a new
process for storing and retrieving electronic case report forms in BIs Document Management System,
developed and implemented a new process to track all submissions filed to FDA. System Business Owner of
IND Serial Number Database.
- Participated in a global implementation team for a Submission Planning and Tracking tool. Generated system
configuration and user requirements, provided support with validation testing, evaluated risks analysis,
prepared and reviewed training materials. Developed global system configuration, evaluated software and
provided direction on requirements for US submissions. Provided expertise as a Key User.
- Co-lead a project team and implemented departmental processes for creating and storing regulatory
documents in new Electronic Document Management system. Participated in Global teams and provided
support with system configuration in accordance with regulatory needs as a Key User and Global Business
- Assigned staff to specific projects and supervised equitable distribution of group workload. Prepared resource
projections; allocated resources to meet the goals of the company. Prepared ad hoc and annual expense,
capital and personnel budget requests for incorporation into departmental budget.
- Contributed to national and international working groups to define, refine and harmonize business processes
per newly established Regulatory Operations structure.
Lisa Girolametti 203-448-0188 Page 2

Manager, Drug Regulatory Affairs Operations 2001 - 2009

Managed seven full-time employees and two temporary employees. Delivered regulatory liaison support for
routine or daily submissions. Recognized and received 2001 Vice President Team Award for first electronic
- Ensured adequate resources were assigned to prioritized submissions.
- Authored and revised internal working instructions and standard operating procedures
- Worked on a variety of special projects; for example, participated in vendor selection and testing for
eCTD software to build electronic submissions to FDA.
- Defined strategies for ensuring documents required by health regulators were in compliance with FDA,
ICH guidelines and corporate polices.

Registration Coordinator/Specialist, Drug Regulatory Affairs 1995 - 2001

Collected, compiled, coordinated and submitted routine and daily IND/NDA submissions to FDA including IND
Annual Reports, Information and Protocol Amendments, Supplements, Responses to FDA Request for
Information, Briefing Packages and Labelling submissions.
- Compiled company's first fully electronic NDA following 1999 FDA eNDA Guidance; submission
- Interacted with various medical and nonclinical colleagues to coordinate release of drug shipments to
clinical trials throughout the U.S.
- Prepared submissions for archiving and conducted searches within Documentum.

Administrative Assistant, Quality Assurance 1990 - 1995

Provided secretarial/administrative support to Director, Quality Assurance. Worked independently with minimal
or no direction, prioritized a heavy workload. Used mature judgment with confidential information.
- Maintained required information for Drug Enforcement Agency and the U.S. Food and Drug
Administration. Generated/updated reports, i.e. Computer System Validation Status Report, Quality
Assurance Activity Monthly Report, Variance and Deviation Status Report, Annual Product Reviews.
- Daily interactions with outside consultants and contractors (domestic and international).
- Coordinated and maintained budget schedules, expense reports, and attendance schedules for 27

Secretary, Quality Assurance Supplier Quality 1987 - 1989

Provided secretarial support to the Manager, Quality Assurance Supplier Quality and staff of four. Duties
consisted of typing correspondence, travel arrangements, maintaining and filling supplier certification records.

EDUCATION: Berkeley College, White Plains, New York

Associates Degree in Applied Science

COMPUTER SKILLS: MS Office, Adobe Acrobat, Documentum, FirstDoc, EZSubs Publishing, ISI Toolbox,
Insight Publisher, eCTDXPress, Beyond Compare, FileZilla, Clinical Trial Management System, Electronic
Submissions Gateway - AS2


Diversity & Inclusion Champion Award sponsored by Boehringer Ingelheim
Danbury School and Business Collaborative (DSABC) Program