Biologics Development & CMC: Strategy & Regulatory Leader
Basis Set
Basis Set is seeking a Head of Biologics Development & CMC to lead development of therapeutic proteins using our egg-based biomanufacturing platform. You will own protein development and CMC strategy across downstream process development, analytical development, product characterization, and regulatory CMC, guiding a small team and coordinating with cross-functional partners. The ideal candidate has deep biologics experience, can bridge science and regulatory strategy, and has led programs #J-18808-Ljbffr Basis Set
- Neion Bio is seeking an exceptional Head of Biologics Development & CMC to drive protein development and CMC strategy for an egg-based platform. You will own downstream... ...development, product characterization, and regulatory CMC, while leading a small team and collaborating...Regulatory
- Travere Therapeutics is seeking a Senior Manager for CMC Regulatory Affairs to lead global regulatory strategies supporting biologics development. This role engages with cross-functional teams to ensure compliance and oversees regulatory interactions globally. The ideal...RegulatoryRemote job
- BeiGene, Ltd. is seeking an AD, Regulatory Affairs CMC dedicated to developing and implementing global regulatory strategies for market access. You will manage CMC aspects through all development phases and coordinate with key stakeholders. The ideal candidate will have...Regulatory
- Fosun Pharma USA Inc. is seeking a Regulatory Affairs CMC leader to steer global CMC regulatory strategies for development and commercial products. This role oversees preparation, review, and submission of high-quality CMC dossiers and ensures compliance with global regulatory...Regulatory
$170k - $230k
...take advantage of novel biological environments to solve... ...Head of Biologics Development & CMC to lead the development... ...development and CMC strategy, spanning downstream... ...characterization, and regulatory CMC. This is a role... ...highly collaborative leader who can move fluidly...Regulatory- ...Manager, Security Compliance at GitLab, you will lead the development of security compliance strategies and enhance GitLab's certification portfolio.... ...various departments, you'll oversee compliance with regulatory requirements while driving automation in processes. The...Regulatory
- NewAmsterdam Pharma Corporation is seeking a Senior Manager CMC Regulatory Affairs to oversee global CMC regulatory strategies for clinical development programs and marketing applications. The role is remote and emphasizes collaboration with various departments to ensure...RegulatoryRemote job
$190k - $230k
...Intelligence (AI) Transformation Leader is responsible for owning... ...defines and leads the AI strategy, ensuring AI is embedded into... ...and foundational capability development across three parallel workstreams... ...governance, privacy, and regulatory expectations, balancing...RegulatoryWork experience placementLocal area- The Regulatory Affairs CMC will lead global CMC regulatory strategies for development and commercial products. This role is responsible for the preparation, review, and submission... ...in the pharmaceutical, biotech, or biologics industry, with at least 3-5 years in a leadership...RegulatoryContract work
$176.4k - $228.25k
...own. The Impact You’ll Make Lead development and implementation of CMC regulatory strategy for small molecule... ...accountability, we enable trust and autonomy—leaders take accountability for decisive... ...‑stage TechBio company decoding biology to radically improve lives. Recursion...RegulatoryLocal areaRemote workWork from homeWorldwide- Iovance Biotherapeutics is seeking an Associate Director of Regulatory Affairs to lead drug development programs. This role involves managing interactions... ...development and a strong background in regulatory strategy. Minimum 10 years in regulatory affairs is required, and...Regulatory
- ...Therapeutics is seeking an Associate Director/Director of Drug Product CMC to lead external manufacturing oversight for mAbs and... ...and PFS delivery systems, partnering with QA, Supply Chain, and Regulatory CMC. The candidate will drive risk assessment, lifecycle improvements...RegulatoryRemote job
- A mid-sized CRO is seeking a Therapeutic Strategy Lead to shape clinical development strategies and serve as a senior subject matter expert... ..., building relationships with key opinion leaders, and contributing to regulatory strategies. The ideal candidate holds an advanced...RegulatoryRemote job
- ...a senior biotech scientist to deliver DS strategies for biologics commercialization, oversee cell culture process development and regulatory filings for PPQs and BLAs, and collaborate... ...and ensure commercial manufacturing and CMC development meet regulatory expectations...Regulatory
- Iovance Biotherapeutics is seeking a Director, Regulatory CMC to oversee drug development programs and regulatory strategy. You will lead cross-functional teams, ensuring high-quality submissions to health authorities. With a minimum of 10 years of experience in regulatory...Regulatory
- ...industry cloud, is hiring a General Manager, CMC to own all aspects of building this new business. Reporting to the VP of Regulatory, you will lead a high‑performing team to... ...capabilities, navigate ambiguity, and set strategy where no playbook exists. You will partner...Regulatory
- ...We’re committed to the development of novel therapies,... ...targets, and novel cytokine biology. Our therapeutic... ...strategic and operational IT leader for Dispatch Bio — a... ...applications and data strategy that scales with the... ...positions us well for regulatory scrutiny, and ensures...RegulatoryTemporary workFlexible hours
$130k - $200k
...products and a pipeline of development candidates. The... ...both small molecules and biologics to treat pain,... ...Associate Director Thought Leader Liaison (TLL), Fibromyalgia... ...Director, Commercial Strategy and will lead... ...Understanding of legal and regulatory issues impacting pharmaceutical...RegulatoryTemporary workWork at officeLocal areaFlexible hours- ...a Global Head of Payroll to lead, design, and execute the company's global payroll strategy across all regions. This strategic role requires deep payroll expertise and strong regulatory knowledge, ensuring compliance and operational excellence. The successful candidate...Regulatory
$200k - $225k
Syndax Pharmaceuticals is seeking an Associate Director, Regulatory Strategy based in New York, NY. This position will lead the development and implementation of regulatory strategies for products, ensuring compliance with global regulations while collaborating with internal...RegulatoryRemote job- ...high-visibility role involves overseeing compliance policies, regulatory engagement, and ensuring adherence to CFTC and NFA requirements... ...integrity, making a significant impact in shaping compliance strategies. This position is located in New York, New York. #J-18808-Ljbffr...Regulatory
- Precision Medicine Group is seeking a Director of CDx Strategy & IVD Regulatory Consulting. This role is based remotely in the United States and involves guiding regulatory affairs and developing business solutions for life sciences companies. The ideal candidate will hold...RegulatoryRemote job
- A leading renewable energy firm is seeking a Licensing Manager to support engineering development for nuclear regulatory compliance. You will prepare and maintain licensing documentation, coordinate with engineers and regulators, and contribute to strategic licensing decisions...RegulatoryFlexible hours
- ...Scientific is seeking a Director of Drug Substance CMC to lead the development of innovative small molecule therapeutics in New... ...leadership role, you will drive drug substance strategy and ensure compliance with regulatory expectations while collaborating with cross-...Regulatory
- Job Description NewAmsterdam Pharma (NAP) is seeking a Senior Manager CMC Regulatory Affairs who will support the development and execution of global CMC regulatory strategies for clinical development programs, initial marketing applications (NDA, MAA, ANDA), and post‑approval...RegulatoryLocal areaRemote work
- Hirebridge is looking for a Regulatory Specialist to lead the development of regulatory strategies for medical devices. This role involves direct client interaction, participating in business development and ensuring compliance with global regulations. The successful candidate...Regulatory
- Customers Bancorp Inc is looking for an AI Strategy & Risk Manager to oversee AI initiatives... ...activities, ensuring alignment with compliance and regulatory standards. With a focus on collaboration, you will partner with business leaders, technology teams, and compliance...Regulatory
- Jobtailor in the United States is seeking a senior leader to drive global Quality processes, including CAPA, deviations, change... ...will partner with cross-functional teams to align Quality strategy with regulatory expectations and operational needs across a global network....Regulatory
$230k - $270k
...new Senior Director, Global Strategy and Program Management ,... ...serves as the Global Program Leader (GPL) and strategic lead for... ..., bringing together development, regulatory, medical, commercial, and market... ...understanding of oncology drug, biologic, or medical device...RegulatoryWork at officeLocal areaFlexible hours3 days per week- ...Executive Director, Commercialization to lead global launch strategies and governance frameworks. This leadership role is... ...will have robust experience in new product development, project management, and regulatory compliance, ensuring that innovative products are market...RegulatoryFlexible hours
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