Manage the monthly, quarterly, and annual financial close processes to ensure accuracy and regulatory compliance. Oversee accounts payable, equity administration, and internal control procedures while mentoring accounting staff.
Celcuity Inc.
11 Remote Job Openings at Celcuity Inc.
Responsible for reviewing and verifying executed batch records, analytical data, and quality control results to ensure compliant product release. The role involves managing documentation in eQMS, communicating with CMOs, and implementing QA standard operating procedures.
Associate Director, Drug Safety and Pharmacovigilance
Celcuity Inc.
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Full Time
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a month ago
Celcuity Inc.
Provide strategic and operational leadership for clinical safety activities, including oversight of end-to-end safety operations and external vendors. Lead the authorship of aggregate safety reports and ensure compliant safety oversight across clinical trials.
Responsible for medical oversight of drug safety and pharmacovigilance activities, including medical triage, signal detection, and risk management for marketed and developmental products. The role involves managing safety vendors, ensuring regulatory compliance, and preparing aggregate safety reports and agency queries.
Executive Director, Regulatory Affairs, Global
Celcuity Inc.
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Full Time
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a month ago
Celcuity Inc.
Lead and develop innovative global regulatory strategies to maximize success for ex-US marketing applications and clinical trial applications. Oversee regulatory submissions, ensure compliance with global requirements, and mentor direct reports.
The Director will serve as the technical expert for API synthesis production and lead the selection, transfer, and management of CDMO manufacturing activities. They are responsible for ensuring regulatory compliance, optimizing synthetic routes, and supporting formulation development through impurity identification and IND-enabling documentation.
Senior or Principal Scientist, Formulation and Process Development
Celcuity Inc.
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Full Time
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2 months ago
Celcuity Inc.
The Senior or Principal Scientist will lead formulation and process development projects across the product lifecycle, including pre-formulation, dosage form selection, and manufacturing scale-up. They will also manage outsourced activities at contract laboratories and CDMOs while serving as a subject matter expert for the Pharmaceutical Development group.
The Director, MSL will be responsible for scientific exchange with healthcare providers and key decision-makers regarding Celcuity’s products and relevant disease states. They will also assist in identifying clinical trial sites and provide scientific training to internal colleagues.
The Senior Medical Director will provide medical oversight for clinical studies and ensure compliance with regulatory standards. Responsibilities include designing clinical study protocols, monitoring ongoing trials, and providing clinical input for regulatory documents.
The Senior Auditor is responsible for planning, leading, and executing complex internal and external GxP audits. This role also involves assessing compliance issues and leading initiatives for continuous improvement.
Director, Medical Science Liaison, North Central
Celcuity Inc.
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Full Time
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4 months ago
Celcuity Inc.
The Director, MSL will be responsible for scientific exchange with healthcare providers and key decision-makers regarding Celcuity’s products and relevant disease states. They will also assist in identifying clinical trial sites and provide scientific training to internal colleagues.
