Senior Regulatory Affairs Specialist
Company: VirtualVocations
Location: Lakeland
Posted on: February 8, 2025
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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, Lakeland , Senior Regulatory Affairs Specialist, Other , Lakeland, Florida
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