James L. Johnson Jr.

** *********** ******

Hamilton, NJ 08619

ad39ig@r.postjobfree.com

ad39ig@r.postjobfree.com

609-***-****

PROFESSIONAL EXPERIENCE:

Regulatory Specialist

Johnson & Johnson, Raritan, NJ (Contract) Jan 2022-Nov 2023

Support Country Specific Registration for the MDR and other projects.

Ensure that records are accurate and complete.

Compare submitted records to corresponding Market Specific Product Transformation Requirement (MSPTR) Form.

Regulatory Affairs Associate

Abbott, Scarborough, MA (Contract) May 2021-Oct 2021

Documenting, evaluating, investigating, maintaining and reviewing complaints to ensure that they are processed in a timely manner.

Protocol Writer

Renaissance, Lakewood, NJ (Contract) Mar 2020-Oct 2020

Review and edited material prepared by other writers and professional staff for accuracy.

Worked closely with personnel from S&M, R&D, Finance, Operations, Regulatory and Quality to obtain all relevant information needed to finalize the template and adhere to the project schedule.

Maintained records and files of work and revisions utilizing databases for tracking templates and associated document workloads.

Associate Regulatory Specialist

Revlon, Edison, NJ (Contract) Apr 2019-Sep 2019

Provided document verification proofing of packaging and labeling artwork versus BOH and/or MLI to assure compliance with required local country format and style guidelines.

Responsible for maintaining and updating regulatory documents into folders and on share point.

Performed audits for documentation systems.

Regulatory Affairs Data & System Analyst

Boehringer Ingelheim, Hamilton, NJ (Contract) Jul 2017-Dec 2018

Responsible for the preparation, tracking, compilation, publishing and technical quality control of all regulatory submissions.

Completed internal and external audits for client compliance.

Regulatory/Submissions Coordinator

Bristol-Myers Squibb Co., Hopewell, NJ May 2000-Mar 2017

Documenting, evaluating and maintaining electronic regulatory files, cases from incoming faxes, emails, and other supporting regulatory documents.

Reviewed documents to assure the data consistency and that regulatory guidelines and format are followed.

Supervised, assisted and provided on-the-job training and support to other safety coordinators.

Recalled archived reports through Records Management; placed batch requests to have reports sent out.

EDUCATION / TRAINING:

Bachelor’s Degree, Business Management, Kean College, Union, New Jersey

Associate degree, Business Administration, Middlesex County College, Edison, New Jersey

Technical Skills:

Microsoft Office – Word, Excel, Microsoft Outlook, and Skype for Business, Serial Number Database, BIRDS for Advanced Authors, Documentum (Archiver, First Doc, Lorenz Validator), Liquent InSight Publisher, AWARE, CARES, Argus, WebTrader, eSubmitter, iPAMS, Salesforce, MDRiM

Certifications:

Online training certificate courses in AWARE HQ Submissions, Data Privacy for AWARE and AWARE System Overview.

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