Regulatory Affairs Manager (Compounding Pharmacy)

Regulatory Affairs

Los Angeles, CA, US

• Added - 02/12/2024

Apply for Job

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

Direct Hire Opportunity!

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.

INDBH

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.