Regulatory Affairs Associate Jobs in New Jersey

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9 New Jersey Regulatory Affairs Associate jobs found on Monster.

Jobs 1 to 9 of 9
Job Responsibilities - Define global CMC regulatory strategy for ANDA filing of injectable products and manage the preparation, assembly and review of the quality (CMC) sections of regulatory submissions. - Liase with FDA in written communications - Coordinate responses to global regulatory agencies dealing with quality sections of global regulatory submissions Qualifications - At least bache...
JOB SUMMARY: Compile, review and transmit eCTD submissions to FDA. Maintain indices, records and processes for all regulatory applications. Maintain GDUFA Self-Identification processes. Demonstrate solid teamwork with RA team members; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality eCTD submission information to support company goals and objectives. ESSENT...
Our client is currently seeking a REGULATORY AFFAIRS ASSOCIATE - Contract position BA/BS in Scientific discipline required. Engineering strongly preferred RAC certification desired Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines. Participate in cross functional team activities from initial stages to securing goven...
Requirements: Minimum of a BS with 1-3 years’ experience in Medical Device industry Recent Experience with complaint investigation and MDR/Vigilance reporting preferred Excellent working knowledge of US (QSR) and OUS Quality Systems (ISO 13485) Responsibilities: Receive, document, and respond to product complaints according to global regulatory requirements, and SOPs Process product complain...
REGULATORY AFFAIRS ASSOCIATE II Summary: Under general supervision, performs routine duties in the preparation, review and submission of pre-and post-approval submissions to the Food and Drug Administration, using governmental guidelines and regulations. Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duti...
BD (Becton, Dickinson and Company) Franklin Lakes, NJ
About us Description Responsibilities: Platform Representation: Representing the Regulatory Affairs function on the (specimen) Cell and Biomarker Preservation and (specimen) Acquisition Platform Teams and associated sub-teams as the Regulatory Affairs subject matter expert (SME) for FDA and CE requirements. This will include acting as a liaison between the Platform team and BD PAS Regulatory Af...
Becton Dickinson and Company Franklin Lakes, NJ
Description Responsibilities: Platform Representation: Representing the Regulatory Affairs function on the (specimen) Cell and Biomarker Preservation and (specimen) Acquisition Platform Teams and associated sub-teams as the Regulatory Affairs subject matter expert (SME) for FDA and CE requirements. This will include acting as a liaison between the Platform team and BD PAS Regulatory Affairs, Int...
BD (Becton, Dickinson and Company) Franklin Lakes, NJ, 07417
Responsibilities: Platform Representation: Representing the Regulatory Affairs function on the (specimen) Cell and Biomarker Preservation and (specimen) Acquisition Platform Teams and associated sub-teams as the Regulatory Affairs subject matter expert (SME) for FDA and CE requirements. This will include acting as a liaison between the Platform team and BD PAS Regulatory Affairs, International (i...
BD (Becton, Dickinson and Company) Franklin Lakes, NJ, 07417
Description Responsibilities: Platform Representation: Representing the Regulatory Affairs function on the (specimen) Cell and Biomarker Preservation and (specimen) Acquisition Platform Teams and associated sub-teams as the Regulatory Affairs subject matter expert (SME) for FDA and CE requirements. This will include acting as a liaison between the Platform team and BD PAS Regulatory Affairs, Inte...

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Regulatory Affairs Associate

Salaries

$38,760.00 - $94,500.00
Typical Salary for Regulatory Affairs Associate in New Jersey
(111 Respondents)
Source: Monster.com Careerbenchmarking Tool

Education / Training

Bachelor's
38.8%
Master's
38.8%
Associates
9%
Some College Coursework Completed
4.5%
High School
3%
Doctorate
3%
(67 Respondents)
Source: Monster.com Careerbenchmarking Tool

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