Regulatory Affairs Coordinator
3 days ago
Position Overview
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
Responsibilities
Specific 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.
The Candidate
Education, Experience, and Licenses:
- 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.
- Understanding of international regulatory requirements, a plus.
International Vitamin Corporation (IVC) Is an Equal Opportunity Employer. Our organization remains steadfast in our commitment to fostering an inclusive and non-discriminatory work environment that welcomes individuals from all backgrounds. We firmly maintain the belief that every individual ought to be treated with respect and dignity, regardless of their race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, veteran status, marital status, genetic information, or any other protected characteristic, as defined by the law. We pledge that all eligible job applicants shall receive an impartial and unbiased evaluation during the recruitment process, without any form of discrimination based on any of the protected class. Our dedication to promoting diversity and inclusivity remains unwavering, and we take immense pride in cultivating a workplace culture that values and celebrates differences. Our efforts towards creating an environment that is free from prejudice and discrimination are an integral part of our organizational philosophy, and we stand committed to upholding these principles.
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