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 Manager to play an exciting role across their innovative processes in LA! Must have minimum of 3 years working in a pharmacy.

Schedule: Mon-Fri -8am-5pm (Hybrid)

Salary: $120-150K

Responsibilities:

• 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:

• PharmD degree with 3 years of experience working in a pharmacy or wholesale distributer.

• Expertise with FDA and EMA and guidelines within industry.

• Holds an active pharmacist license.

Astrix

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Pharmaceutical Regulatory Affairs Specialist