Manager - Trade Compliance Scientific Specialist
November 27
Description
• Lead global trade compliance program for biological materials. • Ensure compliance with regulations set by FDA, USDA, and other relevant agencies. • Provide training and education regarding compliance rules and regulations. • Develop global regulatory strategies and trade compliance risk mitigation plans. • Engage in effective communication with cross-functional teams and lead audits. • Develop and enhance internal processes for creating high-quality procedures.
Requirements
• Bachelor’s degree in pharmacy, Biology, Chemistry, or Microbiology. • A minimum of 8 years' experience in regulatory exposure in global regions beyond the US and EU, such as Asia. • Proven ability to navigate complex regulatory issues and requirements effectively. • Knowledge of animal health industry regulatory guidelines under FDA, EMA, USDA, and other regulatory agencies. • Ability to travel (domestic/international) approximately 15-20%. • Working knowledge and understanding of current regulations and industry trends for biologics product development and manufacturing. • Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices. • Ability to manage complex work and global projects. • Strong communication skills, both verbal and written. • Proficiency in Microsoft Office (particularly Word and Excel) and other computer systems for filing and tracking supplements and reports. • Ability to meet statutory deadlines and business timelines to accomplish company objectives.
Benefits
• Medical, Dental, and Vision Insurance Options • Life and Disability Insurance • Paid Time-Off • Parental Benefits • 401k with Company Match • Employee Stock Purchase Plan
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