Administrator, Regulatory Support
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Overview
POSITION SUMMARY STATEMENT:
Provides regulatory administrative support to Regional Regulatory Affairs Teams in the Americas.
Work cross-functionally with various domestic and international departments, necessary for completion of all printed components, FSF, compliance reviews & CFS for GRA teams in the Americas.
DETAILED RESPONSIBILITIES/DUTIES:
• Effectively communicates by e-mail, telephone and in person with marketing contacts, manufacturers, and other departments on a daily basis about all aspects of tasks assigned to RSA.
• Develops new and revised printed components through defined workflows in Agile, ensuring their regulatory compliance prior to printing.
• Responsible for routing printed component ECOs through the Agile system and follows up with others pending their approvals of the PC ECOs.
• Maintains and updates product databases.
• Requests documents such as affidavits, CFS, Additives letters, notifications, and certifications and conducts follow ups to assure completion.
• Reports project statuses to the direct supervisor on a weekly basis, through meetings established by the department head, or through reporting, as necessary.
• Maintains daily project statuses for GRA regional teams.
• Communicates to direct supervisor any potential changes that could improve efficiencies within and outside of the RSA role.
• Maintains updated documentation/KPIs control sheets.
• Carries out all responsibilities in an honest, ethical and professional manner.
• Works closely with corresponding regional Regulatory Affairs Specialists, and cross-functionally with various domestic and international departments, necessary for completion of designated activities.
Job Qualifications
Qualifications:
1. Skills:
Required
• Detail-oriented approach.
• Excellent organizational skills and ability to multitask and adapt to flexible environment.
• Ability to adapt in a fast-paced setting with evolving goals and objectives.
• Autonomous approach.
• Excellent written & verbal communication skills.
• Team oriented with good people skills.
Preferred
• Ability to interact effectively at all levels throughout the organization, with sensitivity to cultural diversity.
• Ability to work under pressure.
2. Experience:
Required
• Experience is not required.
Preferred
3. Education:
Required
• Bachelor´s degree in nutrition, biology, chemistry, food science, pharmacy or engineering.
• Fully Bilingual (Spanish/English).
Preferred
• Intermediate level in Portuguese.
• Intermediate level in French.
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