Administrator, Regulatory Support

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.
 

SUPERVISORY RESPONSIBILITIES: None
 

Qualifications:

1.    Skills: (List 3+ required and preferred skills or abilities)
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: (List 3+ required and preferred experience criteria)
Required
•    Experience is not required.

Preferred

3.    Education: (List required and preferred education/certification criteria)
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.