Bilingual- Regulatory Affairs Specialist
Phoenix area pharmaceutical company is expanding their international business portfolio and needs a Spanish speaking Regulatory Affairs Specialist. Professional environment with a knowledgeable and vibrant team.
GENERAL DESCRIPTION: Performs the organization, preparation, and publication of document packages for regulatory submissions. Drafts and recommends changes to content of labeling, and provides advice on content of submissions that includes reviewing reports for regulatory compliance. Monitors and improves document tracking and control systems. Keeps abreast of regulatory procedures and changes.
Documents and tracks regulatory communication between the company and international Regulatory Agencies and corporate partners in Latin America.
Assists in the management of project timelines and provides operational regulatory support to project teams and Senior Management.
Performs regulatory intelligence assessments that review regulatory precedent, Agency opinions, and competitor product information and industry practices to guide the development of successful company regulatory product strategy.
Assists in the maintenance of the Regulatory Affairs electronic document management and electronic dossier publishing systems.
Serves as a regulatory liaison to international partners who are in the process of organizing and preparing dossier submissions to Regulatory Agencies. Responds to request for clarification of information presented in food product documentation.
Maintains a current knowledge of food and dietary supplement legislation, which impacts the company’s activities and products. Alerts management for any relevant legislation and its impact on the company.
Works closely with R & D, Quality Management and other department to clearly convey need of regulatory document and adhere to time lines for the same.
All other duties as assigned.
Bachelor’s degree in scientific or health discipline or equivalent.
Fluent in Spanish – written and verbal - fluency will be evaluated during the interview period; will be required to submit writing samples
Written Communication: Writes clearly and concisely. Edits work. Presents data effectively. Able to read and interpret written information
Oral Communication: Speaks clearly and persuasively. Listens and gets clarification when necessary. Responds professionally and informatively to questions.
Professional demeanor and appearance
Broad knowledge of Regulatory Affairs, experience in Quality Assurance and Document Control.
Demonstrated organizational skills, and attention to detail.
Strong proofreading skills.
Must be knowledge of current regulatory requirements including GMP.
Must possess good interpersonal, organizational, and project planning skills.
3 to 5 years’ experience in Regulatory preferred