Regulatory Compliance Specialist
7 days ago
Job Summary:
This role is responsible for ensuring compliance with regulatory requirements for products manufactured at all facilities, including contract facilities. The candidate will maintain the regulatory reporting calendar for submissions and communicate with customers and state agencies regarding compliance information.
Key Responsibilities:
- Communicate and track customer-specific and state agency-related regulatory compliance information.
- Maintain the regulatory reporting calendar for submissions.
- Review regulatory intelligence sources to provide direction and recommendations on new and upcoming regulations.
- Create whitepapers on new regulations to document internal procedures and provide basis for communications to customers.
- Review and advise on risks documented in Safety Data Sheets.
- Audit complaints to ensure compliance with internal procedures on Adverse Event Reporting and timing.
- Review and approve label proofs.
Requirements:
This position requires a Bachelor's degree with 2 years of Quality or Regulatory experience or equivalent Quality or Regulatory experience. The candidate should have excellent attention to detail, organizational, and communication skills. Experience with FDA representatives regarding filing of OTC drug registrations and OTC establishment registrations for products and manufacturers is preferred.
Work Environment:
This job operates in a professional office environment. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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