Easter Seals Jobs

Regulatory Affairs Manager

Regulatory Affairs

Los Angeles, CA, US

Pay Rate Low: 120k | Pay Rate High: 150k

• Added - 11/11/2024

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Our partner specializes in their patented resources and ingredients, servicing the community with their profound discoveries globally in the biopharma space. They are searching for a Regulatory Affairs Manager (with a minimum of 3 years working in a pharmacy)to play an exciting role across their innovative processes in Los Angeles, CA

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:

• Doctor of Pharmacy required with a minimum of 3 years working in a pharmacy or wholesale distributor

• Expertise with FDA and EMA and guidelines within industry

• Holds an active pharmacist license

INDBH

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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.