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 - $100k
Direct Hire Opportunity!
Requirements:
• Collaborate with teams to develop regulatory processes for pharma products.
• Provide insight to teams, providing education on regulations.
• Oversee applications and review all submissions.
• Manage an audit program for compounding pharmacies.
• Oversee licensing regulations, and assist distributors on 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.
Requirements:
• Doctor of Pharmacy (PharmD) is required.
• Holds 2-3 years of experience of relevant experience.
• Expertise with FDA and EMA and guidelines within industry.
• Holds an active pharmacist license.
