Regulatory Compliance Manager

The Regulatory Compliance Manager will develop and align the organization to ensure Good Manufacturing Practice (GMP) and regulatory compliance in the labeling, manufacturing, packaging, and distribution of supplements by the company.  In addition, they will oversee and manage label compliance, international product registration and documentation according to applicable regulations as it relates to National and International regions of business.

• Manage product registrations with Health Canada, TGA and other international markets
• Evaluate compliance issues by monitoring trends and industry standards and recommend remedial actions required
• Review and approve investigation and remedial action reports and make regulatory decisions
• Assure product label and literature compliance with FDA and FDC regulatory obligations
• Assist co-workers and internal customers with interpretation of regulatory requirements (e.g., GMPs)
• Oversee product label development and international documentation

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Kristine O’Sullivan at kosullivan@cps4jobs.com.

JO:  70.23BKO
#LI-KO1

Technical Qualifications:

• BS/BA in a related Science field and/or Regulatory Science
• 3-5 years of regulatory compliance experience and/or training education equivalent combination of experience
• 3 years’ experience in an FDA regulated manufacturing facility
• TGA, EU European Union, Health Canada certification experience (Preferred)
• CMQ/OE (Manage of Quality/Operational Excellence), CQA (Quality Auditor), Six Sigma Green or Black Belt training desired

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Kristine O’Sullivan at kosullivan@cps4jobs.com.

JO:  70.23BKO
#LI-KO1