Regulatory Affairs Coordinator

International Vitamin Corporation•AND-Anderson, SC

13d

About The Position

The Regulatory Affairs Coordinator supports regulatory compliance activities within the organization. This role involves ensuring that products meet all regulatory requirements and standards, both domestically and internationally

Requirements

Bachelor’s degree in a related field (e.g., Regulatory Affairs, Biology, Chemistry, Pharmacy).
1-3 years of experience in regulatory affairs within the pharmaceutical, dietary supplement, or related industry preferred.
Knowledge of FDA regulations and guidelines preferred.
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.

Nice To Haves

Understanding of international regulatory requirements, a plus.

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.