DescripciónDescriptionThe Regulatory Professional under the direction of a Site Regulatory Affairs Lead will assist in the creation, review and submission of regulatory documents and facility registration documents and may be the regulatory contact for a submission / site project under the supervision of a more experienced regulatory affairs representative.
Requisitos RequirementsRequirements:
Experience in manufacture, quality or distribution in Pharmaceutical/Biotech industry
Strong oral and written communication skills in English and Spanish
Proficiency working with teams at different levels
Able to operate in a fast paced, dynamic environment
Education:
Master degree or Bachelor degree and 2 years of related experience in a pharmaceutical industry environment or Associate’s degree and 6 years of experience in a pharmaceutical industry environment or High school diploma / GED and 8 years of experience in a pharmaceutical industry environment
Educational background in Biotechnology, Microbiology or Chemistry is preferred
BeneficiosBenefits PackageEducation:
Master degree or Bachelor degree and 2 years of related experience in a pharmaceutical industry environment or Associate’s degree and 6 years of experience in a pharmaceutical industry environment or High school diploma / GED and 8 years of experience in a pharmaceutical industry environment
Educational background in Biotechnology, Microbiology or Chemistry is preferred
FUNCTIONS
- Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations, variations/supplements, country specific documents coordination).
- Provide and maintain CTA/MA documentation support (e.g. annual reports, amendments) in collaboration with the Site Regulatory Lead.
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