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Company Name:
Thermo Fisher Scientific
Approximate Salary:
Not Specified
Baltimore, MD
United States
Position type:
Experience level:
Education level:
Job Title:
Regulatory Affairs Compliance Senior Specialist - East Coast US

Regulatory Affairs Compliance Senior Specialist - East Coast US

Job Description

Job Title: Regulatory Compliance Senior Specialist
Requisition ID: 75130BR

When you join us at Thermo Fisher Scientific, you ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information
Remote/ Field East Coast US - any major city

How will you make an impact?

As a Regulatory Compliance Specialist working in the LSG Global Regulatory team, you will be empowered to make decisions and provide technical expertise to our internal stakeholders to enable continued market access of our products globally.

The Regulatory Compliance Specialist is responsible for the coordination of export and import regulatory guidelines as well as development and adherence to compliance policies and procedures for LSG. The position emphasizes managing Import/Export regulatory compliance data and assisting management in the resolution of issues that may arise, including interaction with Global Trade Compliance, Product Management, R&D and as necessary with government officials from FDA, USDA, Fish Wildlife and other government agencies across the globe that enable product movement within- country and across borders.

What will you do?

  • Assist in the creation and adherence of export and import regulatory compliance policies and procedures for LSG regarding shipments containing animal origin components. Share procedures and best practices across other divisions and groups with Thermo Fisher.
  • Manage the accuracy of product compliance data used during import/export processes, ensuring compliance to all US Government Laws and Regulations (including USDA, FDA, Fish & Wildlife, and Public Health) and other government agencies in rest of world. Prepare formal responses for questions specific to imported or exported products. NOTE: does not include responsibility for CBP related documentation or trade compliance in the U.S.
  • Continually track and maintain changes to regulations related to animal origin and define strategies to avoid potential conflicts.
  • Liaise with in-country experts to establish standard import and export requirements for new product introduction, including any end user licenses or applications that may be required.
  • Liaise with the Global Trade Compliance team, as well as other internal teams and Regulatory Agencies to ensure data transmitted to the brokers and internal customers is accurate and meets specific country import requirements.
  • Advise on classifications for international product data for the Company s products: Country of Origin, Animal Origin, and FDA product codes, USDA import permits, etc.
  • Provide input as requested on new international distribution pathways to ensure compliance with the import/export regulations and the business needs.

How will you get here?
  • A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
  • Minimum 2 years experience in importing and exporting in the Life Sciences industry OR 2 years Life Sciences industry experience including using or applying for Veterinary Permits for Importation of Controlled Materials, Organisms and Vectors.
  • Strong working knowledge and understanding of APHIS importing requirements and Biosecurity requirements in general.
  • Strong ability to influence others and interpret government regulations.
Knowledge, Skills, Abilities
Desired Profile:
  • High energy level; positive attitude; works well under stress, Strong communicator, Team player.
  • Hands-on, action-oriented, and able to implement effectively through his/her team.
  • Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency.
  • Able to work autonomously in a matrix-managed organization.
  • Willingness to travel (~10-15%).
  • Comfortable with ambiguity and change.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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