Regulatory Affairs Specialist: Compliance Strategy Leader

CJ America Bio; Downers Grove (IL); Vor Ort; USD 60.000 - 80.000; Vollzeit

Zusammenfassung

A prominent food science company is looking for a Regulatory Affairs Specialist to support the Regulatory Affairs Manager in ensuring compliance with regulatory standards. This role involves managing audits, responding to regulatory inquiries, and developing regulatory strategies for product submissions. Candidates should have a relevant bachelor's degree and at least 2 years of experience in regulatory affairs. Strong organizational, analytical, and communication skills are essential, along with knowledge of FDA regulations.

Qualifikationen

• Bachelor's degree in food science, chemistry, biology or related field, master's preferred.
• 2 years of directly related experience preferred.

Aufgaben

• Assist RA Manager in responding to regulatory agencies.
• Develop relationships with state or federal regulatory agencies.
• Identify and interpret relevant regulatory guidelines.
• Manage audits and regulatory agency inspections.
• Participate in preparation of regulatory agency applications.

Kenntnisse

Organizational skills

Leadership skills

Analytical skills

Communication skills

Time management skills

Ausbildung

Bachelor’s degree in food science, chemistry, biology, or related field

Master’s degree preferred

Tools

FDA regulations knowledge

cGMP experience

HACCP certification

Jobbeschreibung

A prominent food science company is looking for a Regulatory Affairs Specialist to support the Regulatory Affairs Manager in ensuring compliance with regulatory standards. This role involves managing audits, responding to regulatory inquiries, and developing regulatory strategies for product submissions. Candidates should have a relevant bachelor's degree and at least 2 years of experience in regulatory affairs. Strong organizational, analytical, and communication skills are essential, along with knowledge of FDA regulations.