Regulatory Affairs Specialist
34790 Ardentech Court Fremont, CA 94555
- 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.
- 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.
- 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.