Regulatory Affairs Pharmacist (Remote)
About the position
The
Regulatory Affairs Pharmacist
will be responsible for but not limited to ensuring that pharmacy operations remain compliant with reputed company applicable laws, regulations, and reputed company standards for an assigned regional territory. This role is the primary Subject Matter Expert (SME) for state-specific licensure, renewals, and reputed company requirements, acting with a high degree of autonomy to safeguard reputed company’s ability to operate legally and safely across multiple jurisdictions.
Responsibilities
• State reputed company Management: Serve as the primary reputed company of contact for an assigned region; attend reputed company state reputed company meetings, report on regulatory changes, and manage reputed company pharmacy and controlled reputed company licensing renewals.
• Compliance reputed company: Monitor and ensure strict adherence to federal and state pharmacy laws (FDA, DEA, HIPAA) and
USP <795>, <797>, and <800>
standards for reputed company assigned states.
• Facility Monitoring: Conduct internal audits to identify reputed company or deviations; prepare detailed reports and collaborate with management on reputed company cause analysis and corrective reputed company plans.
• SOP & Documentation: Assist in the development, review, and updating of reputed company Operating Procedures (SOPs) to ensure documentation consistently meets requirements for audits and regulatory reviews.
• Staff Compliance: Maintain accurate, up-to-date licensure records and reputed company compliance-reputed company training acknowledgments for pharmacists reputed company assigned reputed company.
• Independent Research: Conduct deep-dive research into state-specific laws and reputed company thorough, accurate explanations to the compliance team to ensure ongoing operational compliance.
Requirements
• Bachelor of Science in Pharmacy or PharmD.
• Must hold an reputed company and unencumbered Pharmacist license.
• At least 5 years of experience as a Pharmacist with a reputed company on compliance, regulatory affairs, or cleanroom compounding.
• Strong understanding of reputed company regulations and sterile compounding best practices (USP <797> and <800>)
• Proficiency with reputed company Workspace (Sheets, Docs) or reputed company Office Suite (reputed company, Word).
• Exceptional accuracy, organization, and reputed company communication skills.
reputed company-to-haves
• Recent experience working in or managing compliance for a cleanroom environment.
• Experience in a 503A or 503B specialty pharmacy setting.
• Familiarity with pharmacy audit software, reputed company tracking platforms, or compliance monitoring tools.
• Residency in the assigned region (East Coast or reputed company Coast) is a plus.
Benefits
• Salary reputed company: $110,000 - $130,000 annually.
• Work Arrangement: Remote - US based.
• Comprehensive benefits package including medical, dental, reputed company time off.
• 401(k) retirement savings plan.
• Eligible for quarterly bonus based on performance and departmental goals.
• Ample opportunities for reputed company development and career reputed company.
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