Celcuity
Senior Manager, Regulatory Affairs, CMC
Celcuity, Minneapolis, Minnesota, United States, 55400
Title: Senior Manager, Regulatory Affairs, CMC
Location: Remote
Position Summary We are seeking a Senior Manager of Regulatory Affairs, CMC who will report into the Associate Director of Regulatory Affairs. The role involves collaborating with internal team members and external contractors to provide regulatory guidance and ensure compliance throughout the development of oncology products. You will develop productive partnerships with internal stakeholders and key vendors to produce high‑quality regulatory submissions. Knowledge of CMC global regulations is essential to support ongoing global clinical trials and review global submissions. The position establishes standards and performs submission activities, including original writing, preparation of CMC regulatory documents, creation of regulatory project timelines, managing submission tracking, document collection, and archival to ensure timely, compliant, and high‑quality regulatory submission management.
Responsibilities
Provide strategic CMC regulatory leadership to support global development and commercialization of drug candidates.
Write and maintain CMC sections of INDs and IMPDs for global CTA’s, ensuring complete, compliant, and timely submissions.
Support generation of CMC documents, compiling, reviewing, approving, and submitting high‑quality CMC sections of INDs/CTAs, NDA/MAA, including responses to regulatory authorities and collaboration with SMEs in Pharmaceutical Development, QC/QA, Supply Chain, and other CMC partners.
Maintain responsibility for all CMC regulatory timelines, including developing timelines for IND/CTA (IMPD)/NDA/MAA submissions, updating SmartSheet, communicating, and escalating any timeline issues to management for on‑time filing.
Act as the regulatory representative on clinical study teams and product development teams, providing guidance on regulatory CMC guidance under the supervision of Regulatory Affairs leadership.
Evaluate proposed manufacturing changes for global impact on ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
Provide regulatory support for quality systems such as change control, discrepancy management, and inspection management; assess proposed pharmaceutical development (CMC) changes and provide strategic guidance to enable global implementation.
Evaluate business impact through regulatory intelligence of all changes related to regulatory CMC regulation or adoption of new regulation that impact CMC processes or CMC strategy.
Interact with vendors as needed to support electronic publishing and other aspects of regulatory operations and submission preparation.
Perform detailed quality reviews of published submission output to ensure compliance with regulatory standards.
Track and archive submissions, correspondence, and commitments with health authorities.
Develop and/or maintain standard operating procedures, department working practices, templates, and style guides.
Ensure the company adheres to all applicable government regulations, submission regulations, and guidelines.
Other duties as assigned.
Qualifications
Bachelor’s degree in a science or health‑related field (e.g., biology, chemistry, pharmacology) or relevant experience; preferred.
Eight or more years of submission/publishing Regulatory Affairs, Regulatory Operations, or Regulatory Project Management experience in a biotech/pharmaceutical setting.
Excellent command of GMPs, GLPs, and GCPs.
Demonstration of cross‑functional understanding related to drug development.
Understanding of ICH and FDA guidance relevant to electronic regulatory submissions.
Experience in preparation of global regulatory submissions with a primary focus on electronic publishing of US IND and/or NDA sequences; experience with CTA and MAA helpful.
Ability to work independently with direction and within project teams and see all projects through to completion.
Excellent verbal and written communication skills.
Strong organizational skills, including the ability to prioritize workload.
Strong people skills and the ability to deal effectively with others.
Ability to meet deadlines and perform multiple tasks in a fast‑paced setting.
Maintain a positive, approachable, and professional attitude.
About Celcuity Celcuity is a clinical‑stage, publicly traded biotechnology company dedicated to extending the lives of cancer patients through targeted therapies for multiple solid tumor indications. The company’s lead candidate, gedatolisib, is an intravenous, first‑in‑class PI3K/AKT/mTOR inhibitor. Celcuity is an Equal‑Opportunity Employer and is committed to fair and equitable compensation practices.
Compensation & Benefits Base salary range: $165,000‑$175,000 DOE, plus eligibility for an annual performance incentive bonus and a new‑hire equity package. Celcuity offers a comprehensive benefits program that includes medical, dental, vision, 401(k) match, paid time off, and paid holidays.
Recruiter Notice Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors are prohibited from contacting our hiring manager(s), executive team members, or employees directly.
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Location: Remote
Position Summary We are seeking a Senior Manager of Regulatory Affairs, CMC who will report into the Associate Director of Regulatory Affairs. The role involves collaborating with internal team members and external contractors to provide regulatory guidance and ensure compliance throughout the development of oncology products. You will develop productive partnerships with internal stakeholders and key vendors to produce high‑quality regulatory submissions. Knowledge of CMC global regulations is essential to support ongoing global clinical trials and review global submissions. The position establishes standards and performs submission activities, including original writing, preparation of CMC regulatory documents, creation of regulatory project timelines, managing submission tracking, document collection, and archival to ensure timely, compliant, and high‑quality regulatory submission management.
Responsibilities
Provide strategic CMC regulatory leadership to support global development and commercialization of drug candidates.
Write and maintain CMC sections of INDs and IMPDs for global CTA’s, ensuring complete, compliant, and timely submissions.
Support generation of CMC documents, compiling, reviewing, approving, and submitting high‑quality CMC sections of INDs/CTAs, NDA/MAA, including responses to regulatory authorities and collaboration with SMEs in Pharmaceutical Development, QC/QA, Supply Chain, and other CMC partners.
Maintain responsibility for all CMC regulatory timelines, including developing timelines for IND/CTA (IMPD)/NDA/MAA submissions, updating SmartSheet, communicating, and escalating any timeline issues to management for on‑time filing.
Act as the regulatory representative on clinical study teams and product development teams, providing guidance on regulatory CMC guidance under the supervision of Regulatory Affairs leadership.
Evaluate proposed manufacturing changes for global impact on ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
Provide regulatory support for quality systems such as change control, discrepancy management, and inspection management; assess proposed pharmaceutical development (CMC) changes and provide strategic guidance to enable global implementation.
Evaluate business impact through regulatory intelligence of all changes related to regulatory CMC regulation or adoption of new regulation that impact CMC processes or CMC strategy.
Interact with vendors as needed to support electronic publishing and other aspects of regulatory operations and submission preparation.
Perform detailed quality reviews of published submission output to ensure compliance with regulatory standards.
Track and archive submissions, correspondence, and commitments with health authorities.
Develop and/or maintain standard operating procedures, department working practices, templates, and style guides.
Ensure the company adheres to all applicable government regulations, submission regulations, and guidelines.
Other duties as assigned.
Qualifications
Bachelor’s degree in a science or health‑related field (e.g., biology, chemistry, pharmacology) or relevant experience; preferred.
Eight or more years of submission/publishing Regulatory Affairs, Regulatory Operations, or Regulatory Project Management experience in a biotech/pharmaceutical setting.
Excellent command of GMPs, GLPs, and GCPs.
Demonstration of cross‑functional understanding related to drug development.
Understanding of ICH and FDA guidance relevant to electronic regulatory submissions.
Experience in preparation of global regulatory submissions with a primary focus on electronic publishing of US IND and/or NDA sequences; experience with CTA and MAA helpful.
Ability to work independently with direction and within project teams and see all projects through to completion.
Excellent verbal and written communication skills.
Strong organizational skills, including the ability to prioritize workload.
Strong people skills and the ability to deal effectively with others.
Ability to meet deadlines and perform multiple tasks in a fast‑paced setting.
Maintain a positive, approachable, and professional attitude.
About Celcuity Celcuity is a clinical‑stage, publicly traded biotechnology company dedicated to extending the lives of cancer patients through targeted therapies for multiple solid tumor indications. The company’s lead candidate, gedatolisib, is an intravenous, first‑in‑class PI3K/AKT/mTOR inhibitor. Celcuity is an Equal‑Opportunity Employer and is committed to fair and equitable compensation practices.
Compensation & Benefits Base salary range: $165,000‑$175,000 DOE, plus eligibility for an annual performance incentive bonus and a new‑hire equity package. Celcuity offers a comprehensive benefits program that includes medical, dental, vision, 401(k) match, paid time off, and paid holidays.
Recruiter Notice Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors are prohibited from contacting our hiring manager(s), executive team members, or employees directly.
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