Our partner, a leader in innovative biopharma resources and patented ingredients, is seeking a Regulatory Affairs Specialist to join their Los Angeles team. This role offers a chance to contribute to groundbreaking developments and regulatory processes with a global impact.
Schedule: Monday-Friday, 8am-5pm (Hybrid)
Salary: $85,000 - $100,000
Employment Type: Direct Hire
Key Responsibilities:
- Develop and support regulatory processes for pharmaceutical products.
- Educate internal teams on industry regulations.
- Manage and review regulatory applications and submissions.
- Oversee audit programs and licensing compliance for compounding pharmacies.
- Conduct audits, inspections, and compliance assessments for regulatory adherence.
- Serve as the main contact with regulatory agencies and healthcare professionals.
- Identify and address compliance risks; implement corrective actions.
- Review product labels and marketing materials for compliance.
- Coordinate documentation with contract manufacturers.
- Keep stakeholders informed of regulatory updates and prepare compliance reports.
Requirements:
- Doctor of Pharmacy required.
- 2-3 years of relevant regulatory experience.
- Knowledge of FDA and EMA guidelines in the biopharma industry.
- Active pharmacist license.