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US Regulatory Affairs Specialists-NY/NJ

The US office has just started a search for direct hire and freelance Regulatory Affairs Specialists. Experienced Regulatory professionals are needed to work on-site at our client location in Northern New Jersey. You will join Pharmalink Consulting as a part of our network of over 2000 professionals worldwide providing all major Regulatory Affairs services in the key Healthcare verticals of Pharmaceuticals, Biotech, Clinical, Consumer Healthcare, Medical Devices, Nutraceuticals and Veterinary.
In this project you will:
• Liaise with manufacturing
• Manage submissions,
• Oversee plant conformance
• Interact with CMC and MA groups
• Support regulatory compliance audits
• Change control contact
Requirements:
• BS or higher in Chemistry, Pharmacy or related discipline.
• 6-10 years of Regulatory Affairs

Apply below for consideration! Must be currently authorized to work in the US.

Location
New Jersey, US

Client

Job Type
Employee or Consultant



Interested? Apply Now.


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  10. Relevant Skills
  11. Prescription Drugs*
  13. Biotech*
  15. Devices*
  17. OTC*
  19. Generics*
  21. CMC eg review/preparation of QOS*
  23. Manufacturing compliance*
  25. Audit work eg CMP, GLP, GCP*
  27. Clinical eg review of protocols, IB, CSRs, Module 2 & 5 documents*
  29. Postmarketing maintenance eg variations/sNDA, postmarketing commitments/safety reporting*
  31. Regulatory operations eg CTD/eCTD/dossier preparation*
  33. Original NDA/MAA filings*
  35. Labeling*
  37. Advertising and promotion*
  39. Regulatory strategy eg RA meetings, filing strategy*
 


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