Manager, Trade Compliance Scientific Specialist

Overview:

We are seeking an experienced Manager, Trade Compliance Scientific Specialist to lead our global trade compliance program for biological materials. The ideal candidate will have extensive knowledge of international regulations governing the export and import of animal products, human-derived materials, and other biological substances across 20+ jurisdictions.

This role requires:

• Proven expertise in managing global trade compliance for diverse biological materials
• Strong leadership skills to guide teams in achieving multi-national regulatory compliance
• Ability to navigate complex regulatory landscapes and interact effectively with various international agencies
• Deep understanding of scientific principles related to animal, human, and synthetic biological products

The successful candidate will play a crucial role in ensuring Revvity's compliance with global trade regulations while supporting our mission to advance science and improve human health.

Key Responsibilities:

• Interpreting regulations pertaining to the exporting and importing of biologics in the countries where we do business. 
• Lead the development and implementation of a trade compliance program for biologics, encompassing animal, human, and biochemical products intended for research use.
• This program will ensure compliance with regulations set by the FDA, USDA, and other relevant agencies overseeing the use and trade of products of animal and human origin, as well as biochemicals and virus-derived products.
• Provide training and education to the Revvity organization regarding the rules and regulations and internal controls required to comply with them.
• Build strong collaboration and processes with R&D, Product Management,  manufacturing, Clinical, Quality and Distribution to ensure coherence with these regulations.
• Oversee the preparation of permit and license submissions and documents required for export or customs clearance, ensuring they meet current regulatory standards and are of high quality.
• Develop and implement global regulatory strategies, ensuring technical accuracy and regulatory compliance.
• Devise robust global trade compliance “biologics” risk mitigation plans.
• Engage in effective communication and collaboration with cross-functional teams to coordinate efforts and achieve compliance and operational excellence.
• Lead and participate in government agency audits, interactions or meetings.
• Preparation global guidelines and internal controls to support the program.
• Develop and enhance internal processes for creating high-quality procedures and work instructions.
• Stay current on regulatory intelligence, including guidelines and new requirements.
• Develop an audit program.

Basic Qualifications:

• 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.

Preferred Qualifications:

• 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.

Who You Are:

• You have demonstrated experience in leading highly engaged teams to achieve.
• company objectives.
• You understand the structure, key roles, and responsibilities of external 
• customers/stakeholders and communicate effectively.
• You lead the organization to adapt to evolving regulatory environments and 
• requirements.
• You proactively create innovative regulatory strategies to avoid obstacles and accelerate.
• worldwide approvals.
• You effectively partner with stakeholders to provide the best solutions and develop.
• relationships that influence the direction of the company and its products.
• You bring out the best in people and teams, fostering an atmosphere of openness and trust.