Regulatory Affairs Project Management
Resume:
JEAN HALLORAN
908-***-**** (Cell) ****.************@*******.***
PROFESSIONAL SUMMARY
Experienced and dedicated Regulatory Professional with over sixteen years of Regulatory experience in the pharmaceutical industry with a strong focus on FDA Submissions. Flexible and dedicated team player with the ability to work independently and efficiently in a fast-paced environment
PROFESSIONAL SKILLS
• Sound organizational and analytical skills
• Excellent written and verbal communication skills
• Polished interpersonal skills
• Strong project management skills
• Strong integrity and ethics
• Solutions-oriented
• Grasps new concepts quickly
• Builds effective partnerships
PROFESSIONAL EXPERIENCE
SANOFI, Bridgewater NJ (Contractor) October 2020 – October 2022
Regulatory Affairs Specialist
Global Regulatory Affairs CMC – 2 year assignment
Manage Vault Registration Tracking for regulatory CMC submission for Global marketed products including creation, initiation of workflow, closing and archiving in Vault
Represent RA CMC managers to ensure the proper entry of CMC registration information, maintenance of up-to-date submission records, management of life cycle CMC registration in Vault in alignment with process
Plan, manage and track status of regulatory CMC submissions (variations /supplements), regulatory impact for variations, publishing requests with creation of core packages and related administrative activities, including information and data entry and uploading submission documentation
Maintain up-to-date CMC registration tracking including updates to registered information and report on approval status and Health Authority correspondences
MALLINCKRODT, Bedminster NJ (Contractor-part-time) August 2019 – February 2020
Regulatory Affairs Document Specialist
Regulatory Affairs Medical Team – 6 month assignment
Manage Veeva submission binder/structure assembly for Regulatory Affairs submissions such as
annual reports, briefing documents, safety reports, labeling changes, CMC changes and general correspondence
Provide quality control review of Regulatory Affairs documents and content
Support RA with other Veeva tasks as needed
Collaborate daily with all functional groups (CMC, Clinical, Labeling)
Assist with MS Word/Starting Point questions for Veeva, Starting
Point and Please Review prepared by or the Regulatory Affairs (RA) department (GPS, GRLs, Regulatory Writing)
SANOFI, Bridgewater, NJ 2002 - 2017
Regulatory Submissions Specialist June 2014 – September 2017
US Regulatory Affairs for Marketed Products
Manage the planning, compilating, and timelines of high-quality electronic FDA
Submissions
Compilation of information for annual reports (AR), abbreviated new drug application reports
(ANDA), periodic adverse event reports (PADER), periodic safety update reports
(PSUR), prior-approval supplements (PAS), biologics license application (BLA), and
Changes being effective (CBE) labeling submissions (specific to Module 1)
Preparation of eTOC’s (electronic table of content) for NDA AR, ANDA, BLA, PADER and PSUR
Submissions (specific to Module 1)
Initiate call for contribution notifications for Annual Reports
Act as regulatory submissions gatekeeper for regulatory operations
Utilize applications such as DOMASYS, SAP, eCTD (electronic Common Technical Document)
Viewer, and Excel
Collaborate daily with all functional groups (CMC, Clinical, Labeling)
Support departmental initiatives, vision and missions
Labeling Operations Specialist June 2013 – June 2014
US Regulatory Affairs for Marketed Products (US RAMP)
(Assigned Temporary Position)
Manage labeling proof-reading services for FDA submissions, and implementation in
Manufacturing and promotion.
Order output of Labeling Package Inserts
Disseminate formatted outputs to internal customers
Update Global labeling databases
Manage the revision of Structured Product Labeling (SPL)
Regulatory Submissions Specialist 2006 – June 2013
US Regulatory Affairs for Marketed Products (US RAMP)
Manage the planning, compilation and timelines of high-quality electronic FDA
Submissions
Compilation of information for annual reports (AR), abbreviated new drug application reports
(ANDA), periodic adverse event reports (PADER), periodic safety update reports
(PSUR), prior-approval supplements (PAS), biologics license application (BLA), and
Changes being effective (CBE) labeling submissions (specific to Module 1)
Preparation of eTOC’s (electronic table of content) for NDA AR, ANDA, BLA, PADER and PSUR
Submissions (specific to Module 1)
Initiate call for contribution notifications for Annual Reports
Act as regulatory submissions gatekeeper for regulatory operations
Submission of structure product labeling (SPL) to FDA’s Office through ESG Gateway
Utilize applications such as FDA ESG Gateway (Electronic Systems Gateway), DOMASYS, SAP,
eCTD (electronic Common Technical Document) Viewer, and Excel
Collaborate daily with all functional groups (CMC, Clinical, Labeling)
Support departmental initiatives, visions and missions
Coordinator 2003 – 2006
US Regulatory Affairs for Marketed Products (US RAMP)
Provide administrative and management support for a Vice President and direct reports
Prepare travel arrangements and expense reporting as well as calendar management
Interface daily with all levels of management
Assistant Facilities Coordinator, Facilities (Contract Position) 2002 – 2003
Company was previously called AVENTIS
Coordinate and administer the internal move processes
Support tall requests through to completion in a timely and professional manner
Prepare the internal move requests with the appropriate internal teams
Communicate regularly with clients and outside vendors
Verify and update vendor monthly reports in various systems
SPECIAL SKILLS
Veeva Vault RIM, SharePoint, Microsoft Outlook, Word, Excel, Workday, Insight Viewer, ECC (Electronic Change Control), DOMASYS, USPI Ordering and Repository Systems
EDUCATION
AXIA COLLEGE, UNIVERSITY OF PHOENIX
Associates Degree
3.84 GPA
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