Senior Regulatory Affairs Associate - Thinknicity

Position Description

Job Number: C11282

Job Title: Senior Regulatory Affairs Associate

Location: Redwood City, CA

Job Type: Contract

Salary: DOE

Contact Details:
· Jessica Gottstein
· (415) 247-7700.
· jessica@thinknicity.com

Eligibility Requirements
· Relocation expenses are not available for this position.
· No resumes from third party agencies representing their own candidates.
· Position cannot entertain candidates requiring visa-transfer or sponsorship.

Thank you.

Job Description
· 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.
· 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.

Candidate Requirements
· Bachelor Degree.
· 5 – 8 Years Experience in Regulatory 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.
· May travel up to 25%.

How to Apply

Application Instructions / Send a Resume