Senior Regulatory Affairs Associate (Temporary Position) - Core Logic, Inc.

Position Description

Job Title: Senior Regulatory Affairs Associate (Temporary Position)
Location: CA/Central


Main Purpose of Position:

This position will support the Regulatory Affairs Department with submission needs, management of documents, files and assisting with the leadership of the Regulatory Affairs department.

Main Duties and Responsibilities:

• Preparation and maintenance of regulatory submissions including standard submissions, health authority meeting requests and packages, full INDs/CTAs and CTDs/NDAs, supplements and strategic activities for US and equivalent documents for Ex US.
• Prepare, format and compile documents and regulatory packages (submissions for clinical and commercial applications, e.g., INDs, eCTDs, NDAs) intended for submission to US and Ex US Regulatory Authorities, from initial to final draft, review, finalization and publication.
• Manage tasks and provide operational support to Regulatory Affairs.
• Facilitate Quality Control / Quality Assurance interface in document or submission review. Create, review and revise documents/submissions for conformance to ICH guidance and other regulatory directives.

• Create, manage and incorporate revisions to documents/submissions and monitor version control of documents.
• Implement and perform quality control, review of documents and assess whether specific project related documents comply with regulatory requirements and SOPs.
• As requested, assist related departments, including QA and Document Control, Writing and Publishing.
• Perform other reasonably related RA duties as assigned by management.


Requirements:

• Bachelor Degree.
• 5 – 8 Years Experience in Reg Affairs/relevant industry. Experience with FDA filings, and interactions, excellent familiarity with medical and technical terminology is preferred.
• Direct experience with FDA and Ex US regulatory agencies in both Pharm and Device.
• Rigorous attention to accuracy and timelines.
• Strong oral and written communication skills.
• Advanced knowledge of MS Word, Adobe Acrobat, and other publishing tools (ISIToolbox, CoreDossier, and Documentum experience a plus).
• Basic knowledge of MS Excel.
• Excellent understanding of English grammar and punctuation.
• Regularly required to sit and talk or hear.
• Frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls.
• Occasionally required to reach with hands and arms.
• Occasionally lift and/or move up to 20 pounds.
• Specific vision abilities required by this job involve normal vision.

Working Conditions:

• If assisting other departments, may experience 10 to 20% exposure to adverse or hazardous conditions.
• Lift lightweight materials (approximately 10-20 lbs) for publishing work (e.g., several binders, paper supplies, etc).
• May travel up to 25%.

This company’s compensation package includes a competitive salary, stock options, comprehensive benefits package, along with a dynamic corporate culture and supportive team environment.

How to Apply

Application Instructions / Send a Resume