Director of Quality Assurance and Regulatory Affairs Jobs in New Jersey

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1-15 of 48 Jobs

Manager, Regulatory Affairs CMC

  • Tris Pharma
  • Monmouth Junction, NJ
  • 13 hours ago
· Bachelors degree AND minimum 6 years experience in Regulatory Affairs specifically preparing, submitting and maintaining CMC sections of applications in CTD format supporting a pharmaceutical or biotechnology...

Senior Manager, Quality Assurance GCP

  • Intercept Pharmaceuticals, Inc.
  • Morristown, NJ
  • 9 hours ago
high level quality as it relates to Intercept global clinical trials....

Associate Manager, Quality Assurance - Gxp

  • Ptc Therapeutics Incorporated
  • South Plainfield, NJ
  • 22 hours ago
Email Job Job Description Job Description Summary: The Associate Manager, Quality Assurance - GxP is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Clinical Practice...

Director, Regulatory Affairs Strategy

  • Aquestive
  • Warren, NJ
  • 2 days ago
Submissions include IND's and NDA's (including 505(b)(2)), Annual Reports, amendments, Clinical Trial Applications, IND/NDA supplements, expedited program designation requests, and Pediatric Study Plans...

Manager Regulatory Affairs - CMC

  • Merck Company
  • Kenilworth, NJ
  • 2 days ago
Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry Minimum 5 7 yrs of Industry Pharmaceutical industry experience out of 4 years...

Senior Manager - Regulatory Affairs CMC

  • Merck Company
  • Kenilworth, NJ
  • 2 days ago
Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry Minimum 10 12 yrs of Industry Pharmaceutical industry experience out of 6...

Manager, Quality Assurance (GCP)

  • Loxo@Lilly
  • Trenton, NJ
  • 2 days ago
trial regulations and guidelines + Proficient in risk management principles + Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs + Self-motivated with the ability...
As the role develops, will be responsible for review of sections of IND/CTA, NDA/MAA/NDS, and other global submission documents in support of clinical trials and marketing applications, and their amendments...
As the role develops, will be responsible for review of sections of IND/CTA, NDA/MAA/NDS, and other global submission documents in support of clinical trials and marketing applications, and their amendments...

Director, Regulatory Affairs, North America

  • Sanofi
  • Bridgewater, NJ
  • 1 day ago
JOB DESCRIPTION: The US Regulatory Affairs Lead is responsible for the proactive development of innovative and robust US regulatory strategies for pipeline and lifecycle assets in Sanofis Rare...

Associate Director, Regulatory Affairs

  • Glenmark Pharmaceuticals Inc.
  • Mahwah, NJ
  • 1 day ago
Read and understand current FDA guidance(s) and trends, USP general/specific DS/DP monographs, and be familiar with ICH guidelines and post-approval change guidance(s) accordingly....

Senior Director, Regulatory Affairs Cmc, Pharmaceutical Technician

  • Daiichi Sankyo, Inc
  • Basking Ridge, NJ
  • 3 days ago
Search Previous Sr. Scientist/Associate Director, RACMC Pharm Tech Associate Director Global Project Management Strategic Initiatives Next Senior Director, Regulatory Affairs CMC, Pharma Tech...

Manager, Quality Assurance - Validation

  • PTC Therapeutics
  • Pennington, NJ
  • 5 days ago
In-depth knowledge of relevant CFR (Title 21), Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) guidelines including thorough knowledge of appropriate GCP, GLP,...

Senior Director, Regulatory Affairs CMC, Pharma Tech

  • Daiichi Sankyo
  • Basking Ridge, NJ
  • 6 days ago
Job Description Summary This position manages and supports assigned staff within the department and has demonstrated expertise in regulatory affairs for biological drug candidates throughout...
2015 was the year that Sandoz got approval for the first biosimilar in the United States. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and...
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Demographic Data for New Jersey

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Director of Quality Assurance and Regulatory Affairs Online Courses and Training Opportunities

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Auditing is a fundamental skill and an important undertaking for professional accountants. This course introduces auditing and assurance and develops skills involved in the audit process. You will...

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A strong argument can be made that the health care field is one of the most information-intensive sectors in the U.S. economy and avoidance of the rapid advances in information technology is no...

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Salary for Director of Quality Assurance and Regulatory Affairs Jobs in New Jersey

Estimated salary range based on data from US Bureau of Labor Statistics (BLS) and iHireBiotechnology research efforts.

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Licensing / Certification

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Highest Education Level

Director of Quality Assurance and Regulatory Affairss in New Jersey offer the following education background
  • Bachelor's Degree (35.1%)
  • Master's Degree (31.9%)
  • Doctorate Degree (25.9%)
  • Associate's Degree (2.8%)
  • Vocational Degree or Certification (2.0%)
  • High School or GED (1.7%)
  • Some College (0.6%)
  • Some High School (0.1%)

Average Work Experience

Here's a breakdown of the number of years' experience offered by Director of Quality Assurance and Regulatory Affairss in New Jersey
  • 2-4 years (32.1%)
  • 4-6 years (32.1%)
  • 8-10 years (14.3%)
  • 6-8 years (10.7%)
  • 10+ years (7.1%)
  • 1-2 years (3.6%)

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