Administrator, Regulatory Support

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.