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Trade Compliance Analyst I at Avantor

extra holidays - extra parental leave
Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 
Pennsylvania (USA), United States

Offer summary

Qualifications:

Bachelor’s degree in Life Sciences, Minimum of 5 years in Regulatory Affairs, Knowledge of US and Canadian regulations, SAP knowledge required, Solid analytical skills.

Key responsabilities:

  • Identify and communicate regulatory risks
  • Maintain and update regulatory documents
  • Collaborate for regulatory product submissions
  • Ensure compliance with hazardous material shipping regulations
  • Participate in audits and inspections by regulatory authorities
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Avantor Biotech: Biology + Technology XLarge https://avantorsciences.com/
10001 Employees
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Job description

The Opportunity:

At Avantor, people are the most important part of our success because they drive our global performance. That’s why our Operations, Lab Services, Sales, and many other Avantor teams rely on our talent acquisition initiatives to attract, engage and hire the right talent. Avantor’s Trade Compliance vertical is a crucial part of this mix, enabling all our internal teams worldwide to grow beyond their limits.

The Regulatory Affairs Specialists are responsible for ensuring compliance with applicable laws, regulations, and industry standards, and they are crucial in obtaining and maintaining regulatory approvals, and providing regulatory guidance to cross-functional teams, internal and external stakeholders. This role focuses on the AMR region (North and South America, Mexico, and Canada.)

This position will report into the Trade Compliance Manager and is a REMOTE position.

What we’re looking for:

  • Education: Bachelor’s degree in Life Sciences
  • Experience: Minimum of 5 years of relevant experience in Regulatory Affairs.
    • SAP knowledge required.
    • Demonstrated solid analytical skills and a history of identifying and reducing complex and systemic risks within systems or large organizations.
    • Demonstrated knowledge of US and Canadian product regulations, including but not limited to FDA, Health Canada, EPA/CEPA, DEA, and TTB.

Who you are:

  • Strong verbal and written communication skills.
  • Demonstrated ability to deliver quality results and a high level of compliance while managing multiple projects, priorities, and daily workflow.

How you will create an impact:

  • Identify and communicate regulatory risks to internal and external stakeholders.
  • Obtain, review, and update materials for California Proposition 65 labeling.
  • Review new product adds, labeling, coding, restrictions, and requirements in Regulatory FileMaker/SAP
  • Collaborate with internal and external stakeholders to gather necessary data and documentation for regulatory product submissions, ensuring completeness and providing correct and accurate technical review of data or reports.
  • Reviews new and changed part add and Kit Tracker regulatory activities, ensuring local, state, and Federal compliance within the Americans.
  • Ensures compliance with hazardous material shipping regulations- with IATA, DOT, IMDG, and TDG and corrects GHS-compliant SDSs when necessary.
  • Maintain accurate and up-to-date regulatory documentation, including product registrations, BOM Changes for regulations, manufacturing licenses, and technical files.
  • Review and research State Restrictions for invasive plant and animal species to ensure proper regulatory permits, prohibitions, and restrictions are in order.
  • Collaborating with internal and external stakeholders to obtain children’s product certificates.
  • Review of product and manufacturing for potential impact to registrations and licenses.
  • Analyzing and evaluating laws and regulations that apply to determining the impact on company activities.
  • Compiling and overseeing the maintenance of regulatory documentation databases or systems
  • Participate in internal and external audits and inspections by regulatory authorities and assist in resolving findings.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
 
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
 
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Biotech: Biology + Technology
Spoken language(s):
Check out the description to know which languages are mandatory.

Other Skills

  • Verbal Communication Skills
  • Analytical Skills
  • Collaboration

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