Regulatory Affairs Specialist Team Lead I (Scientific)

Vastek Group
Ridgefield, NJ Full Time
POSTED ON 3/13/2023 CLOSED ON 1/7/2024

Job Posting for Regulatory Affairs Specialist Team Lead I (Scientific) at Vastek Group

The Regulatory Compliance Specialist performs the role of a regulatory site officer within the quality organization. Routine regulatory activities include change assessment, dossier development for post-marketing changes, ensuring product and site renewals are completed on time, responding to health authority questions, and maintaining dossier compliance.

Bachelor's Degree in Engineering or Science with 3 or more years of experience in the pharmaceutical industry. Minimum 2 years of regulatory CMC experience required. Employee must be familiar with industry expectations for dossier writing and information expected to be provided for post-market changes.

Job Type: Contract

Salary: From $40.00 per hour

Benefits:

  • 401(k)
  • Health insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Monday to Friday

Supplemental pay types:

  • Bonus pay
  • Signing bonus

Ability to commute/relocate:

  • Ridgefield, NJ 07657: Reliably commute or planning to relocate before starting work (Required)

Experience:

  • FDA regulations: 1 year (Required)

Work Location: One location

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Salary.com Estimation for Regulatory Affairs Specialist Team Lead I (Scientific) in Ridgefield, NJ
$189,234 to $237,019
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