Regulatory Affairs Specialist

Fremont, CA 94555

Posted: 04/26/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 15568

JOB SUMMARY: 
  • Executes regulatory activities for team members or projects in accordance with applicable regulations and guidelines under minimal supervision.
  • Edits and formats regulatory submissions for consistency and completeness prior to sending documents to Regulatory Publisher for processing
  • Organizes and maintains regulatory database by arranging and hyperlinking final submissions and FDA correspondences.

ESSENTIAL JOB FUNCTIONS: 
  • Knowledgeable of IND and NDA submission requirements. 
  • Prepares, and reviews IND annual reports and required submissions to INDs such as investigator updates, safety reports, and annual reports, as well as assistance in preparation of IND amendments. 
  • Prepares and reviews NDA annual reports and required submissions to NDA such as CBE, PAS and safety reports.
  • Coordinates with Regulatory Publisher on submission timing; uploads files to FTP site for regulatory processing.
  • Works with team to ensure documents are in system and performs QC checks on published submissions.
  • Ensures submission documents adhere to document templates.
  • Ensures all data for submission are complete and in compliance with company guidelines and FDA regulatory requirements, such as eCTD format and submission hierarchy.
  • Reviews essential documents required for FDA submission and/or drug release to clinical investigation sties for clinical studies.
  • Communicate with Clinical Operations and CMC teams to resolve issues prior to submission and/or drug release.
  • Prepares regulatory request for proposals and resolves purchase order payment for regulatory team.
  • Approves drug release to clinical sites for in-sourced studies
  • Act as point of contact for collection of required documents from participating departments, and distribution of those documents for review and approval by Regulatory Affairs Management.
EDUCATION and EXPERIENCE: 
  • B.S. in Chemistry, Pharmacy, Biochemistry or other related science discipline is required.
  • A minimum of two years of experience in the pharmaceutical industry with no less than one year in Regulatory Affairs
  • Experience with SPL and eCTD requirements a plus
  • Strong organizational, prioritization, coordination, and collaboration skills
  • Working knowledge of 21 CFR 312 and 314
  • Working knowledge/experience working with GLP and GMP environment
  • Prior experience in regulatory writing- regulatory submission work
  • Excellent analytical skills
  • Strong computer skills in a windows environment, including Microsoft Word, Excel and good editing and proofing skills.
  • Excellent communication, interpersonal and creative problem solving skills.

PHYSICAL DEMANDS:
  • Sitting – 80%
  • Standing/ walking  - 20%
  • Repetitive motion: Substantial movements of the wrists, hands, and or fingers for sustained periods of time. Approximately 6-hours of keyboarding per day.
  • Visual Requirements: Able to see and read PC screens and read fine print.
  • Lifting: Raising objects under 15 pounds from a lower to a higher position or moving objects horizontally from one position to another. 
  • Comprehension: Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints. 
  • Decision Making: Ability to make decisions which have impact on the department’ s credibility, operations, and services.
  • Communication: Ability to formulate complex and comprehensive materials such as legal documents, authoritative reports, official publications of major scope and impact, etc and to make formal presentations. 
  • Mathematics:  Ability to compute, analyze, and interpret numerical data for reporting purposes.  
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