Regulatory Submissions Manager
VirtualVocationsHayward, California, United Statesjob_description.job_card.variable_days_ago
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- serp_jobs.job_card.full_time
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A company is looking for a Regulatory Submissions Manager to support high-priority regulatory activities in the biopharma sector.
Key Responsibilities
Lead and coordinate the preparation, formatting, and submission of regulatory documents for INDs / CTAs and NDA amendments
Manage document lifecycle and submission tracking using Veeva RIM
Collaborate with cross-functional teams to ensure timely and accurate submissions
Required Qualifications
Bachelor's degree in life sciences or related field; advanced degree preferred
Minimum 5 years of experience in regulatory operations or submission management in the biotech / pharma industry
Proven experience with IND and NDA submissions
High proficiency in Veeva RIM
Strong knowledge of eCTD structure and FDA / EMA submission requirements
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Regulatory Manager • Hayward, California, United States
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