Administrator, Regulatory Support
hace 1 semana
*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.
SUPERVISORY RESPONSIBILITIES: None
*Qualifications*
Qualifications:
- 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.
- Experience: (List 3+ required and preferred experience criteria)
Required
- Experience is not required.
Preferred
- 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.
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