Regulatory Affairs Associate Job

Regulatory Affairs Associate is needed to perform the following duties:

• Assessment of formulas, claims, and labeling to ensure compliance with domestic and international laws and regulations.
• Prepare domestic and international documentation to support clients with registration submissions or premarket clearance.
• Prepare and keep current domestic and international facility registrations.
• Stay up to date of regulatory changes in the U.S. and foreign countries and ensure appropriate personnel are updated on such changes.
• Create supplement facts panel, review and approve product labels.
• Responsible for domestic product certifications (e.g. Organic, Non-GMO, Kosher, Halal, etc.).
• Work collaboratively with appropriate company personnel to identify regulatory requirements for products and labels.
• Create and update Standard Operating Procedures.
• Provide regulatory support and advice for clients in response to questions.

Bachelor’s degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science or Pharmacy Administration