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Regulatory Compliance Specialist

2 months ago

Skaneateles, New York, United States Chipton-Ross Full time
Position Overview:
Chipton-Ross is seeking a Regulatory Affairs Specialist III for a remote contract opportunity. This role involves the coordination and preparation of documentation for regulatory submissions, ensuring compliance with industry standards.

Key Responsibilities:
  • Monitor the status and progress of regulatory documentation
  • Review, edit, and proofread regulatory submissions
  • Assist in the preparation and evaluation of labeling, SOPs, and other essential documents
  • Compile regulatory documents for submission under supervision
  • Actively participate in project teams as necessary
  • Prepare responses to inquiries from regulatory authorities
  • Maintain regulatory files in accordance with established requirements
  • Stay informed about current regulatory requirements
  • May oversee a specific product portfolio within the region

Qualifications:
  • Strong scientific knowledge
  • Excellent written and verbal communication skills
  • In-depth understanding of regulatory frameworks
  • Proficient in technical systems (e.g., word processing, spreadsheets, databases, online research)
  • Strong proofreading and editing capabilities
  • Able to contribute to multiple projects from a regulatory perspective
  • Effective multitasking and prioritization skills
  • Bachelor's degree or equivalent in pharmacy or a related scientific field with 2 years of regulatory experience, preferably in a healthcare setting

Education:
Accredited Bachelor's Degree required

Work Hours:
First shift, full time