Regulatory Affairs Coordinator jobs in United States
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International Vitamin Corporation · 1 month ago

Regulatory Affairs Coordinator

International Vitamin Corporation is seeking a Regulatory Affairs Coordinator to support regulatory compliance activities. The role involves preparing regulatory submissions, maintaining documentation, and ensuring compliance with standards in the pharmaceutical and dietary supplement industry.

Health CareTherapeutics

Responsibilities

Assist in preparing regulatory submissions and filings, including FDA submissions, product registrations, and certifications
Maintain regulatory documentation and databases, ensuring accuracy and completeness
Monitor regulatory changes and updates to ensure compliance with evolving standards
Coordinate with cross-functional teams to gather necessary information for regulatory submissions
Support regulatory audits and inspections by preparing documentation and responding to inquiries as needed
Provide regulatory guidance and support to internal stakeholders on compliance matters
Assist in reviewing product labeling and marketing materials for regulatory compliance
Maintain awareness of industry best practices and regulatory trends
Poses no direct threat to the health or safety of himself/herself, of others, or to property. Defined as a significant risk of substantial harm that cannot be eliminated or reduced to an acceptable level by reasonable accommodation
Requires regular attendance to perform essential element as contained herein between the assigned start and end times for work
Performs such individual assignments as management may direct
Other duties as assigned

Qualification

FDA regulationsRegulatory submissionsRegulatory databases/softwareInternational regulatory requirementsTask managementMS Office SuiteAttention to detailOrganizational skillsWritten communicationVerbal communication

Required

Bachelor's degree in a related field (e.g., Regulatory Affairs, Biology, Chemistry, Pharmacy)
Strong attention to detail and organizational skills
Excellent written and verbal communication abilities
Ability to prioritize and manage multiple tasks effectively
Proficiency in MS Office Suite and regulatory databases/software

Preferred

1-3 years of experience in regulatory affairs within the pharmaceutical, dietary supplement, or related industry preferred
Knowledge of FDA regulations and guidelines preferred
Understanding of international regulatory requirements, a plus

Company

International Vitamin Corporation

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For more than half a century, IVC has been producing some of the highest quality dietary supplements for leading retailers in the U.S.

Funding

Current Stage
Late Stage

Leadership Team

S
Steven Dai
President & CEO
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Company data provided by crunchbase