Senior Manager, Regulatory Operations

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Requirements:

• Bachelor’s degree with 8+ years of experience in Regulatory Operations environment within the pharmaceutical industry.
• Experience managing active applications and with ex-US regulatory submission requirements.
• Advanced user of Microsoft suite and Smartsheets.
• Experience with Veeva RIM systems and SharePoint is a plus.
• Familiarity with computer system validation for FDA/EMA regulated systems and understanding of xml and SPL is a plus.

Responsibilities:

• Oversees and manages all regulatory submissions and submission compliance.
• Handles creation, publishing, submission, and archiving of regulatory submissions.
• Manages external publishing staff for health authority submissions.
• Develops and maintains regulatory standards and best practices.
• Evaluates and proposes improvements for regulatory systems.
• Leads regulatory project management activities, including submission planning.