Regulatory Affairs Specialist

Company: International Erosion Control Association
Location: Los Angeles
Posted on: November 6, 2024

Job Description:

Our partner specializes in their patented resources and ingredients, servicing the community with their profound discoveries globally in the biopharma space. They are in search of a Regulatory Affairs Specialist to play an exciting role across their innovative processes in LA!Schedule: Mon-Fri - 8am-5pm (Hybrid)Salary: $85k - $100kDirect Hire Opportunity!Responsibilities:

• Collaborate with teams to develop regulatory processes for pharma products.
• Provide insight to teams, offering education on regulations.
• Oversee applications and review all submissions.
• Manage an audit program for compounding pharmacies.
• Oversee licensing regulations and assist distributors with registrations and compliance.
• Monitor adherence to regulatory standards through audits and inspections.
• Serve as the main contact for regulatory agencies and healthcare professionals.
• Oversee compliance assessments related to change controls, deviations, and GMP investigations.
• Identify compliance risks and implement corrective actions.
• Review product labels and marketing materials for accuracy and compliance.
• Coordinate with CMOs and compounding pharmacies for documentation.
• Stay updated on regulatory changes and inform stakeholders.
• Prepare compliance reports for management with findings and recommendations.Minimum Requirements:
• Doctor of Pharmacy (PharmD) is required.
• 2-3 years of relevant experience.
• Expertise with FDA and EMA guidelines within the industry.
• Active pharmacist license.
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Keywords: International Erosion Control Association, Laguna Niguel , Regulatory Affairs Specialist, Other , Los Angeles, California