Senior Manager, Regulatory Affairs, CMC

November 9

❄️ Minnesota – Remote

Although this job is listed in Minnesota, this company may be open to hiring remote in other states.

💵 $165k - $175k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Celcuity

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Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Provide strategic CMC regulatory leadership to project teams and external stakeholders to support global development and commercialization of drug candidates. • Responsible for writing and maintaining CMC sections of INDs and IMPD’s for global CTA’s while ensuring complete, compliant, and timely submissions. • Provide hands-on support in generating CMC documents, responsible for compilation, review, approval and submission of high-quality CMC related sections of INDs/CTAs, NDA/MAA, including responses to questions from various regulatory authorities. • Maintain responsibility for all CMC Regulatory timelines including developing timelines for IND/CTA (IMPD)/NDA/MAA submissions (new, amendments, supplements, responses to queries), updating SmartSheet, communicating, and escalate any timeline issues to management toward successful on-time filing. • Act as the regulatory representative on clinical study teams and product development teams providing guidance on regulatory CMC guidance. • Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes. • Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. • Assess proposed pharmaceutical development (CMC) changes and provide strategic regulatory guidance to enable global implementation. • Evaluate business impact, through regulatory intelligence, all changes related to regulatory CMC regulation, or adoption of new regulation which impact CMC processes and/or CMC strategy. • Interact with vendors as needed in support of electronic publishing and other aspects of regulatory operations as well as regulatory submission preparation as needed. • Perform detailed quality reviews of published submission output to ensure compliance with Regulatory Standards, as required. • Track and archive submissions, correspondence, and commitments with health authorities as needed. • Develop and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate. • Ensure the company is adhering to all applicable government regulations, submission regulations and guidelines.

🎯 Requirements

• Bachelor’s degree in a science or health-related field (like biology, chemistry, or pharmacy) • Eight plus (8 +) years of submission/publishing Regulatory Affairs, Regulatory Operations, or Regulatory Project Management experience in a biotech/pharmaceutical setting • Excellent command of GXPs (eg, GMPs, GLPs and GCPs) • Understanding of all International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA guidance relevant to electronic regulatory submissions • Experience and knowledge in the preparation of global regulatory submissions with primary focus on electronic publishing of US IND and/or NDA sequences (additional experience with Clinical Trial Authorizations (CTA) and Marketing Authorization Application (MAA) helpful) • Ability to work both independently with direction and within project teams and see all projects through to their 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.

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays • Annual performance incentive bonus • New hire equity package