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Senior Regulatory Affairs Specialist
VirtualVocationsToms River, New Jersey, United Statesjob_description.job_card.30_days_ago
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- serp_jobs.job_card.full_time
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A company is looking for a Senior Regulatory Affairs Specialist (Remote).
Key Responsibilities
Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports
Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols
Develop CMC regulatory strategies to support clinical trial initiation and advancement
Required Qualifications
B.A., B.S., M.S., or Ph.D. in biochemistry, chemistry, biology, or a related pharmaceutical field
Minimum of 10+ years of experience in CMC / regulatory affairs
Hands-on experience authoring and compiling CMC sections of regulatory filings
Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH
Proficiency with regulatory document management systems
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Regulatory Specialist • Toms River, New Jersey, United States
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