Manager Quality Assurance

Bernadette A. Nass

*** ********** ******, ******, ** 07065

Home: 732-***-****

*******@*****.*** Mobile: 908-***-****

SUMMARY

Senior Global Regulatory Operations Specialist with extensive experience supporting all

functions within the pharmaceutical organization. Successful track record of developing

and implementing business strategies and electronic systems that result in high-quality,

time-efficient processes across global function to achieve successful regulatory

approvals. Offer superior computer skills, with an earned reputation for problem analysis,

priority-setting and teamwork. Self-motivated and creative to achieve both personal and

corporate goals.

TECHNICAL SKILLS

Microsoft Office Applications Documentum with First Docs InSight Publisher SmartLink for

MSWord/PDF Liquent eCTD Reviewer Liquent eCTD Viewer Adobe Acrobat Professional Internal

Templates Global Submit Validate PDF Composer ISI ToolBox Pharma Edition Global Submit

Review PitStop Professional ISI Compose Tool FDA Electronic Submission Advanced Core

Dossier Core Dossier Compiler Gateway

PROFESSIONAL EXPERIENCE

HOFFMANN-LaROCHE, INC

., Nutley, NJ 1996 - 2012

Regulatory Operations Information Management

Manager Global

Process (2005-2012)

Managed all aspects of regulatory operations function in support of timely

electronic/paper submission management for all company products while overseeing the

development of technology initiatives to improve regulatory processes.

Effectively supported and led multiple International Drug Product Teams simultaneously as

a subject matter expert of FDA regulations and guidelines. Directed publishing team to

successful compilation of submissions, submitting weeks ahead of standard timelines,

allowing for earlier FDA approval and increased company revenue.

Continued to lead the Regulatory Submission Group in coordinating and producing BLAs,

NDAs, CTD/eCTDs, INDs, MAAs, CTAs and other various submissions as well as individual

reports within the submissions. Validated the eCTD and worked with publishing tools to

ensure quality eCTDs for Health Authorities.

Collaborated with teams, vendors and co-development partners to ensure requirements were

followed in the creation of documents/dossiers and lifecycle management.

Acted as US business leader within team in the development and implementation of a global

validated eCTD system using InSight Publisher, Documentum with First Doc Interface,

Liquent eCTD Reviewer, GlobalSubmit Validate/Review, EURS is Yours Validate/Reviewer and

Liquent eCTD Viewer. Streamlined global resources and processes to work with better

efficiency in a constantly changing environment.

Trained, mentored and provided strategic support to all pharmaceutical areas to ensure

the creation of submissions were done according to the ICH, local health authority and

internal SOPs/guidelines meeting regulatory quality/compliance standards. Oversaw

utilization of the publishing guidelines globally ensuring alignment within organization.

Authored many internal guidelines/SOPs.

Maintained communication with 500+ users of systems and assured appropriate assignment of

users to functional and project groups, keeping all users informed of process and

systematic changes. Collaborated with technical and quality teams on the creation,

implementation, maintenance and management of a Global Publishing System.

Regulatory Operations Information Management

Sr. Associate

(2004-2005)

Developed of compliant electronic submissions for FDA and other international agencies,

including the creation and compilation of quality global regulatory submissions and

lifecycle management submissions, ensuring conformance with regulatory requirements,

guidelines, internal standards and timelines.

Led the Regulatory Submission Group in coordinating and producing BLAs, NDAs, CTD/eCTDs,

INDs, MAAs, CTAs and other various submissions as well as individual reports within the

submissions.

Provided technical support, problem analysis and issue resolution for software

applications used by the project teams in the preparation of documents and dossiers for

submissions to various health authorities. Worked closely with system application managers

on technical issues to ensure they were resolved in a timely manner with minimal impact on

the submission timelines.

Created process between external vendors/business partners to ensure receipt of compliant

documents for submissions which allowed internal resources to be utilized for submission

publishing.

Regulatory Submission Group

Coordinator/Associate

(20012004)

Managed, reviewed and directed the preparation of electronic and/or paper documents for

global regulatory submissions according to the ICH, FDA and local health authority

regulations and guidelines. Applied processes to new or different situations and

identified cause of problems and systemic issues. Modified procedures to support changing

operations and business needs for improvements in work processes.

Regulatory Submission Group

Publishing Specialist/Senior Information Specialist

(19962001)

Member of global regulatory submission group working with all departments involved in

dossier structure. Key deliverables included planning, processing, quality assurance and

shipping all documentation to global health authorities. Responsible member of a global

publishing group that formatted all printed text for new drug applications to be submitted

to various health authorities.

ADDITIONAL RELEVANT EXPERIENCE

PARISH SERVICES, INC

., Rahway, NJ

Manager

of Publishing/Advertising Department

Assistant Manager of Advertising Sales Force

EDUCATION

Medical Office Administration Certification, High Academic Honors, President's List, GPA:

4.0,

The Cittone Institute,

Edison, NJ

Course of Study: Computer Science/Data Processing,

Union County College, Cranford, NJ

Bernadette A. Nass

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Home: 732-***-****

*******@*****.*** Mobile: 908-***-****

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