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Regulatory Compliance Associate

2 months ago

Totowa, New Jersey, United States Englewood Lab, Inc Full time
Regulatory Affairs Associate

Key Responsibilities:

  • Support the Regulatory Affairs Manager during compliance audits.
  • Compile and manage product master files and drug master files.
  • Prepare and review various technical documentation.
  • Develop Raw Material Regulatory statements and assess customer compliance reports.
  • Coordinate investigations and communications related to regulatory audits.
  • Ensure adherence to all Standard Operating Procedures (SOPs) and regulatory standards.
  • Oversee facility registrations, renewals, and submission of documents.
  • Assist in conducting periodic quality assessments and annual Good Manufacturing Practice (GMP) training.
  • Maintain knowledge of SOP generation processes, specification controls, and Quality Management Systems (QMS).
  • Stay updated with evolving global regulatory requirements.
  • Conduct compliance evaluations and generate reports for new product introductions.
  • Prepare, review, and maintain reports pertaining to Cosmos Natural, Cosmos Organic, and NOP standards.

Qualifications:

  • Bachelor's degree in Life Sciences, Engineering, or a related field.
  • Experience with regulatory processes in pharmaceuticals, cosmetics, or medical devices.
  • Knowledge of FDA regulations under 21CFR 210, 211, & 820.
  • Minimum of two years of industry experience in cosmetics, medical devices, food, or pharmaceuticals.
  • Proficient in data analysis and computer applications.
  • Strong communication abilities.

Employee Benefits:

  • Comprehensive Medical, Dental, and Vision Insurance
  • Life Insurance Coverage
  • 401k Retirement Plan with Matching Contributions