Regulatory Affairs Consultant jobs in Elizabeth, NJ

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Manager Global Regulatory Affairs
  • Hired Acumen (an OfficeTroops brand)
  • Jersey, NJ FULL_TIME
  • Our client is an independent, privately owned specialty chemical manufacturing company.


    Job Scope:

    · Reporting to VP/Technology, serve as a subject matter expert for chemical and product specific regulations to ensure regulatory compliance globally.

    · Safety Data Sheet & Label Authoring as required using UL/Wercs software

    · Product set up and Data Maintenance in EH&S SAP module

    · Product Classification - Use relevant regulations to properly classify the Company products

    · Regulation tracking - Keep current with the changing global regulations on hazard communications; communicate to the management in a timely manner relevant changes in global chemical regulations

    · Regulations Implementation - Implement new regulations and maintain SDS’s and labels in compliance with the applicable laws and regulations to assure uninterrupted business operations

    · Assure that SDS’s accurately reflect product compositions in SAP

    · Provide necessary support with REACh registrations and compliance

    · Maintain contact with 3rd party emergency responders and service providers

    · Support activities for determining the proper shipping classification and packaging classification; capture and maintain the same in SAP

    · Work closely with Business, Sales, Supply Chain, Quality and plant EH&S teams to provide regulatory support to the US operations

    · Respond to day-to-day customer inquiries related to regulatory matters

    · Educate/train company employees on regulatory matters to assure that the internal processes ensure compliance with applicable regulations

    · Lead the company’s efforts in achieving and maintaining the Sustainability goals aligned with the industry standards


    Candidate Profile:

    · BS in Chemistry, Biology, Environmental Science, or other related technical discipline

    · 5 years of experience in the Regulatory Compliance/Hazard Communications field

    · Thorough knowledge of current global, federal and state regulations, and an understanding of their impact on hazard communication

    · Excellent interpersonal skills, integrity and professionalism

    · Hands-on experience and a track record with authoring SDS’s and labels using Wercs software, managing projects and personnel

    · In-depth knowledge of and hands-on experience in operating EH&S SAP module

    · Working knowledge of REACh registration process and regulations

    · Familiarity with Sustainability industry standards


    Employment and compensation

    · The successful candidate will be offered a competitive compensation package including benefits.

    · We are an Equal Opportunity Employer

  • 6 Days Ago

A
CMC 2 Regulatory affairs
  • Ampcus Inc
  • Short Hills, NJ CONTRACTOR
  • Job Description: Job Title: CMC 2 Regulatory affairsLocation: Rahway, NJ - OnsiteResponsibilities Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 com...
  • Just Posted

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Director of Regulatory Affairs
  • Lumanity
  • Morristown, NJ OTHER
  • Overview / About us Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate ev...
  • 1 Day Ago

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Regulatory Affairs Specialist
  • Katalyst HealthCares & Life Sciences
  • Short Hills, NJ CONTRACTOR
  • Responsibilities Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports Experienced in authoring of assessment reports and Pa...
  • 2 Days Ago

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CMC Regulatory Affairs
  • VARITE INC
  • Short Hills, NJ CONTRACTOR
  • Job DescriptionPREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5 years in the pharmaceutical industry, preferably with 3 years CMC regulatory experience, Sterile...
  • 2 Days Ago

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Director Advertising & Promotions, Regulatory Affairs
  • Bayer
  • Whippany, NJ FULL_TIME
  • At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it...
  • 4 Days Ago

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0 Regulatory Affairs Consultant jobs found in Elizabeth, NJ area

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Health Systems Oncology Medical Affairs Director (PA, OH, KY, & WV) (Remote)
  • Merck
  • Rahway, NJ
  • **Job Description** Our Medical Affairs team advances patient care by engaging in scientific exchange with external medi...
  • 6/14/2024 12:00:00 AM

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GPV Submission Specialist
  • GForce Life Sciences
  • Princeton, NJ
  • Consultant, GPV Case Management Product Specialist, Pharmaceuticals Summary Our growing, mid-sized pharmaceutical client...
  • 6/13/2024 12:00:00 AM

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Principal Scientist, Clinical Research, Breast Cancer
  • Merck
  • Rahway, NJ
  • **Job Description** Our company is a global health care leader with a diversified portfolio of prescription medicines, v...
  • 6/13/2024 12:00:00 AM

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East Coast Private Wealth Planning Associate
  • Venable LLP
  • New York, NY
  • Venable LLP’s East Coast Private Wealth Planning Group seeks an associate with at least 4-6 years of experience in high-...
  • 6/12/2024 12:00:00 AM

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Global Senior Director Medical Affairs, GMSA Oncology, Thoracic Malignancies (Remote)
  • Merck
  • Rahway, NJ
  • **Job Description** **Global Senior Director of Medical Affairs for Thoracic Malignancies** + The Global Senior Director...
  • 6/12/2024 12:00:00 AM

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Associate Director-Quality Assurance (QA-CMC)
  • Clinical Dynamix
  • Jersey City, NJ
  • Associate Director-Quality Assurance (QA-CMC); Hybrid (There is an opportunity for the position to be bumped up to a Dir...
  • 6/12/2024 12:00:00 AM

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Safety Case Management Product Specialist
  • GForce Life Sciences
  • Princeton, NJ
  • Consultant, GPV Case Management Product Specialist, Pharmaceuticals Summary Our growing, mid-sized pharmaceutical client...
  • 6/10/2024 12:00:00 AM

C
Manager, Cyber Risk & Analysis (Machine Learning)
  • Capital One
  • Newark, NJ
  • Center 3 (19075), United States of America, McLean, Virginia Manager, Cyber Risk & Analysis (Machine Learning) The Enter...
  • 6/10/2024 12:00:00 AM

Elizabeth is both the largest city and the county seat of Union County, in New Jersey, United States.[21] As of the 2010 United States Census, the city had a total population of 124,969, retaining its ranking as New Jersey's fourth most populous city, behind Paterson. [22] The population increased by 4,401 (3.7%) from the 120,568 counted in the 2000 Census, which had in turn increased by 10,566 (+9.6%) from the 110,002 counted in the 1990 Census.[23] For 2017, the Census Bureau's Population Estimates Program calculated a population of 130,215, an increase of 4.2% from the 2010 enumeration, ran...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Consultant jobs
$132,397 to $168,485
Elizabeth, New Jersey area prices
were up 1.6% from a year ago

Regulatory Affairs Consultant
Develop and advise on regulatory strategies to guide biotech, pharma, and/or device companies through development decisions.
October 03, 2022
Contributes to preparation of high-quality regulatory submissions by helping to organize cross-functional activities pertaining to the regulatory function, including the development of meeting requests, timelines, and compilation of briefing documents intended for submission to regulatory authorities.
December 31, 2022
Support clinical, managerial and executive staff, in developing and/or refining systems that support compliance with standards of accrediting bodies, as well as applicable regulation.
March 09, 2023
Participate in solution development that enable adoption of digital capabilities for Life Sciences organizations.
March 30, 2023
Demonstrate the application of clear, accurate and current understanding of Joint Commission requirements, as well as applicable state, local and federal requirements to allow accurate and timely identification of problem areas.
April 24, 2023
Understanding and showing respect and appreciation for the uniqueness of all individuals.
May 13, 2023