Senior Regulatory Affairs Specialist

Company: VirtualVocations
Location: Santa Clara
Posted on: February 8, 2025

Job Description:

A company is looking for a Senior Regulatory Affairs Specialist.

Key Responsibilities

Author and review compliant CMC regulatory documents and support clients in responding to health authority questions
Assess CMC changes and ensure compliance with global regulatory requirements
Organize and track submissions for regulatory agencies, maintaining knowledge of current FDA and EU regulations

Qualifications and Requirements

Bachelor's degree in a health or life science discipline; advanced degree preferred
5+ years of experience in the pharmaceutical industry, with at least 2 years in Regulatory-CMC
Experience authoring CMC sections in regulatory filings and familiarity with CTD formatting
Knowledge of US and European regulations and ICH guidance preferred
Strong computer proficiency in MS Office Suite and experience with regulatory systems and tools

Keywords: VirtualVocations, Santa Clara , Senior Regulatory Affairs Specialist, Other , Santa Clara, California

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