CMC Regulatory Affairs Manager — Cell Therapy
$140k - $160kIovance Biotherapeutics
Iovance Biotherapeutics is seeking a Manager, Regulatory Affairs CMC to spearhead the planning, compilation, and submission of Investigational Drug Applications. Responsibilities include working with diverse internal teams and negotiating with stakeholders to align submissions with regulatory guidelines. This role requires a BA/BS in a relevant field and 8+ years of regulatory experience. Strong communication and organizational skills are essential. The position offers a competitive salary range of $140,000 - $160,000 USD. #J-18808-Ljbffr Iovance Biotherapeutics
$228k - $233k
...advancing transformative therapies for people with cancer... ...2, an investigational cell-based therapy in... ...The Director, Global Regulatory Affairs leads Protara’s ex-US... ...submissions experience and manage study specific regulatory... ...understanding of CMC, nonclinical, and clinical...SuggestedLocal areaRemote workFlexible hours$115k - $145k
About This Role Axsome Therapeutics is seeking a Manager/Senior Manager, Regulatory CMC. This role provides regulatory Chemistry Manufacturing Controls (CMC) support for assigned corporate development and commercial programs and is responsible for the regulatory aspects...SuggestedWork at officeLocal areaRemote work3 days per week- ...Description NewAmsterdam Pharma (NAP) is seeking a Senior Manager CMC Regulatory Affairs who will support the development and execution of global... ...landscape of lipid‑lowering treatment. By advancing innovative therapies for cardiovascular disease (CVD) and other lipid‑related...SuggestedLocal areaRemote work
- Iovance Biotherapeutics is seeking a Director, Regulatory CMC to oversee drug development programs and regulatory strategy. You will lead... ...authorities. With a minimum of 10 years of experience in regulatory affairs, especially in oncology, you will be responsible for creating...Suggested
$120k - $150k
...Supervisor to oversee day-to-day operations of its Stem Cell Lab. The role demands a Bachelor's Degree, NYS DOE... ...years of relevant experience. Responsibilities include managing staff, ensuring compliance with regulatory standards, and maintaining a high-quality work...SuggestedMonday to Friday- ...transform how Americans eat through nutrition therapy. Berry Street’s platform connects... ...Dietitians and AI-powered tools. From weight management, diabetes, and heart health to kidney... ...workflows, and can translate complex regulatory requirements into clear policies, processes...
$110k - $175k
...helping life sciences companies bring therapies to patients faster. As one of the... ...value of our products. As the Manager of Solution Consulting for our Regulatory team, you will empower a high-... ...Regulatory Operations and Regulatory Affairs professionals. Requirements...Work at officeLocal areaWork from homeFlexible hours$200k - $250k
Senior Director, Regulatory Strategy Consulting 4 days... ..., Regulatory Affairs, the Senior Director... ...Development Provide line management and performance management... ..., and/or regulatory CMC. Experience across... ...ADCs), small molecules, cell and gene therapy, oligonucleotides,...Full timeRemote work$230k - $270k
...Global Strategy and Program Management , you'll play a key part... ...together development, regulatory, medical, commercial, and... ...Clinical Development, Medical Affairs, Regulatory, Commercial,... ..., groundbreaking therapy designed to disrupt cancer cell division. With us you will...Work at officeLocal areaFlexible hours3 days per week- ...Legend Biotech is seeking a Sr. Manager, Clinical Trial Operations Planning & Analytics... ...Development, IT, ITQA, Biostatistics, Regulatory, Project Management, Procurement, Finance... ...trial execution preferred. Oncology, cell therapy, or early‑phase clinical development experience...Permanent employmentFull timeFor contractorsLocal area
$161.6k - $202k
...condition, but most providers don't accept insurance, making therapy too expensive for most people. Headway's mission is to fix this... ...(HITRUST, SOC 2, PCI-DSS, HIPAA), third-party risk management, security awareness training, and technical risk management. You...Work from homeFlexible hours- ...leading healthcare provider in New York is seeking a Laboratory Supervisor to oversee daily laboratory operations. The individual will manage staff, ensure compliance with regulations, and maintain the highest quality of patient care. A Bachelor's Degree and a NYS DOE...Full time
- ...intelligence, and end‑to‑end patient support solutions, we accelerate therapy initiation and improve patient outcomes for pharmaceutical and... ...deployment drive meaningful impact. About The Role The Senior Manager, Strategic Finance & Investments is a high‑impact, analytical...Temporary workLocal areaImmediate startRemote work
$246.33k - $304.29k
...Regulatory Affairs Remote – ID: 25R-27 – Full-Time/Regular This position is... ...advance a portfolio of innovative therapies aimed at transforming the... ...(e.g., Product, Clinical, CMC). Proactively identify and... ...Program Leadership Provide people management, coaching, and development...Full timeWork at officeRemote workRelocationFlexible hours$246.33k - $304.29k
...Job Summary Senior Director, Regulatory Affairs to lead global regulatory strategy for vadadustat... ...functional sub-teams (e.g., Product, Clinical, CMC). Proactively identify and mitigate... ...compliant submissions. Provide people management, coaching, and development for direct...- Scorpion Therapeutics is seeking a seasoned professional to lead CMC development and commercialization strategies within the... ...experience and demonstrate a strong capability to navigate complex regulatory environments. Responsibilities include guiding a cross-functional...
$160k - $210k
...reporting needs. Supports monitoring of key Compliance risk areas. Manages time effectively and regularly meets expected deadlines.... ...000—$210,000 USD. OUR OPPORTUNITY Natera™ is a global leader in cell‑free DNA (cfDNA) testing, dedicated to oncology, women’s health,...Temporary workWork experience placementWork at officeImmediate startRemote workWorldwideHome officeWeekend workAfternoon shift$177k - $229.5k
...revolutionize cancer treatment with therapies designed to activate a... ...Summary As the Area Business Manager (ABM) at Replimune, you’ll take... ...knowledge of healthcare regulatory and enforcement environments.... ...intended to maximize immunogenic cell death and the induction of a...Local areaRemote workFlexible hours$152k - $190k
...health condition, but most providers don't accept insurance, making therapy too expensive for most people. Headway’s mission is to fix this... ...mental healthcare for the better. As a Strategic Finance Manager, you will sit within the Strategic Finance GTM team and play a...Work from homeFlexible hours- ...Summary: The Regulatory Affairs Manager ensures regulatory compliance of The Avon/LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Manager will assemble and review all product-related...Contract workFixed term contractLocal areaFlexible hours
- Scorpion Therapeutics is seeking a Manager of Regulatory Affairs Advertising and Promotion to manage regulatory activities for advertising and promotion of marketed products. You will advise on the development of product messages, ensuring compliance with FDA regulations...
- ...a global technology company, building the best way to move and manage the world’s money. Min fees. Max ease. Full speed. Whether... ...for Wise US Assets Inc., while also supporting broader Assets regulatory and operational readiness across North America. The role will provide...
$145k - $160k
...treatments, weight loss, hormone therapies, or regenerative medicine,... ...change. This role involves managing medical oversight and internal... ...uphold the highest standards of regulatory integrity. Key... ...healthcare compliance, regulatory affairs, or risk management —ideally...Remote workFlexible hours$213k - $257.25k
...measurements of protein movement in living cells, thereby unlocking otherwise... ...We are seeking an experienced Director, Regulatory Affairs to support and execute regulatory strategy... ...expertise, rather than formal people management. You bring excellent communication, organizational...Summer holidayWork at office3 days per week$135k - $159.5k
...empowers us to deliver the right care at the right time—whether it’s therapy, coaching, medication, or beyond—tailored to each individual’s... ...of professional experience in strategic alliances, channel management, or business development within the healthcare or benefits...Full timeRemote workSleeping nights$125k - $300k
...pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS... ...and speak clearly and with confidence Demonstrated experience managing projects and working effectively across functions and with peers...Work at officeLocal areaWork from homeFlexible hours$125k - $250k
...pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS... ...with stakeholders at all levels of a client organization, from managers to the C‑suite Customer-Centric Innovation: A strong track record...Work at officeLocal areaWork from homeFlexible hours- ...Theradex is recruiting for Head of Regulatory Affairs Permanent, Full time (Homebased) with 10... ...ensures timely approvals and lifecycle management aligned with business goals. Maintain... ...awareness of the literature on cancer therapy, clinical trial design and conduct Knowledge...Permanent employmentFull timeWork at office
$190k - $240k
...Crédit Agricole Group is seeking a Director for Compliance Coordination and Regulatory Affairs in New York. This senior role involves managing interactions with U.S. regulatory agencies, coordinating audits, and leading high-priority compliance projects. The ideal candidate...- ...Director, Chemistry, Manufacturing, Control for Biologics (Biologics‑CMC) Primary Responsibilities Lead Regulatory CMC team for antibody‑drug conjugates (ADCs) in late‑stage development and life‑cycle management. Own global CMC regulatory strategy, global registration, and...
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