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Regulatory Affairs Specialist

2 months ago

Princeton, New Jersey, United States Laboratoire Guerbet Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Associate to join our team at Laboratoire Guerbet. As a key member of our regulatory team, you will play a critical role in ensuring the accurate and timely submission of all US regulatory documents for medical devices and software-driven medical devices.

Key Responsibilities
  • Participate in pre-submission meetings with FDA to agree on potential regulatory pathways, clarify submissions under review, and follow up on submissions.
  • Coordinate the preparation, review, and submission of e-CTD regulatory dossiers to FDA.
  • Identify relevant FDA CDER, FDA OGD, and ICH guidances for drug products.
  • Provide regulatory advice to the Guerbet RA team on required labeling changes.
  • Conduct regulatory e-CTD training with various Guerbet regulatory employees.
  • Maintain knowledge of existing and new regulations, standards, and guidances.
  • Recommend changes to company procedures per updates in US FDA regulations.
  • Distribute updated information about FDA regulations, FDA, and ICH guidelines.
  • Maintain regulatory files to obtain and maintain drug product approvals.
  • Review promotional materials for compliance with DDMAC requirements.
  • Evaluate labeling of drug products per current FDA labeling requirements.
  • Evaluate Guerbet's CMC documents for compliance with FDA requirements.
  • Write regulatory standard operating procedures, work instructions, and policies.
  • Advise project teams on pre-market and post-market regulatory requirements.
  • Consult on export and labeling requirements for clinical study compliance.
  • Compile and maintain regulatory documentation databases or systems.
Requirements
  • Bachelor's degree.
  • 3-4 years of regulatory affairs experience in the pharmaceutical industry.
  • 3-4 years of hands-on experience with preparation of e-CTD dossiers.
  • 3-4 years of experience in FDA interactions and understanding of the FDA processes.
  • Project management skills for timely publishing of e-CTD regulatory submissions.
About Guerbet

Guerbet is a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital, and AI solutions for diagnostic and interventional imaging. We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law.

We provide accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position, please send an email to.