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Job Code :348 Division :750 - Regulatory Affairs Location :1. TARRYTOWN NY US 10591 2. Tarrytown NY US 10591
% of Travel Required :None Job Type :Full Time Career Level :Experienced (Non-Manager) Education :Bachelor''s Degree Category :Regulatory Affairs Job Description :
The Executive Administrative Assistant/Regulatory Affairs Assistant will prepare regulatory document submissions and provide administrative support to the Vice President of Regulatory Affairs. This position is essential to the department’s effectiveness.
Regulatory Document Submission Responsibilities:
·Compile, process and distribute documentation necessary for FDA and other regulatory health authority submissions.
·Prepare regulatory submissions in electronic format and submit to electronic publishing vendor
·Prepare templates, forms and draft cover letters, collate materials and coordinate retrieval of contents for submissions from multiple departments
·Management and maintenance of regulatory communications and submissions using electronic Access database
Administrative Support to Vice President – Regulatory Affairs
·Process confidential documents and data critical to the regulatory affairs function; plan, prioritize and organize a diversified workload while proactively recommending and anticipating changes in office practices and procedures in a fast-paced environment
·Provide administrative support including calendar management, preparing agreement requests, filing, meeting planning, mail sorting, travel and expense reporting
·Interact with all levels within the organization Job Requirements :
·Advanced skills working with MS Office and Adobe Acrobat, Access and PowerPoint presentations. (i.e. Hyperlink, Bookmarking, Formatting etc.)
·Strong organizational skills, attention-to-detail, and in depth knowledge of general business operations
·General knowledge of eCTD publishing standards, FDA regulations and ICH guidance pertaining to submissions is preferred
·Experience in the Pharmaceutical, Medical, HealthCare, or Biotech industry