Senior Regulatory Affairs Specialist
Company: VirtualVocations
Location: Santa Barbara
Posted on: April 4, 2025
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Job Description:
A company is looking for a Regulatory Affairs Specialist.
Key Responsibilities
Author and review regulatory CMC documents and support client
responses to health authority inquiries
Assess CMC changes and global regulatory requirements, ensuring
compliance with FDA and EMA standards
Organize and manage regulatory submission packages for various
markets, maintaining communication with clients
Qualifications and Requirements
Bachelor's degree in a health or life science discipline is
required; 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 Common Technical Document (CTD) formatting
Knowledge of US and European regulations and ICH guidance is
preferred
Proficiency in regulatory systems and tools, as well as MS Office
Suite
Keywords: VirtualVocations, Bakersfield , Senior Regulatory Affairs Specialist, Other , Santa Barbara, California
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