Regulatory Affairs Specialist

Job Summary

A company is looking for a Regulatory Affairs Specialist, Americas.

Key Responsibilities:

• Supervise and assess regulatory developments across excipient, pharmaceutical, food, and feed industries
• Translate new regulations into actionable implementation plans and ensure compliance
• Collaborate with regulatory bodies to maintain product and site approvals and assist with regulatory submissions

Key Requirements:

• Bachelor's degree or equivalent experience in Life Sciences, Regulatory Affairs, or a related field
• Proven track record in regulatory affairs, preferably in pharmaceutical or related sectors
• Strong knowledge of GMP standards and regulatory frameworks (FDA, USDA, Health Canada, TGA, etc.)
• Experience with regulatory documentation and impact assessments
• Ability to work independently in a remote environment and prioritize tasks effectively