Senior Biotech PM - CMC/Regulatory
BridgeBio Pharma
BridgeBio Pharma is seeking a Senior Manager, Project Management in San Francisco. This hybrid role will support the CMC team and ensure effective communication with internal and external stakeholders. The ideal candidate will have at least 10 years of project management experience in the biotech or pharmaceutical industry. Key responsibilities include organizing team activities, managing multiple CDMOs, and ensuring adherence to project timelines and deliverables. Competitive compensation includes base salary and benefits such as 401(k), stock options, and health insurance. #J-18808-Ljbffr BridgeBio Pharma
$140k - $214k
Vera Therapeutics in Brisbane, California is looking for a Senior Manager, Regulatory CMC to drive regulatory submissions in a collaborative environment. The role involves managing CMC aspects of clinical products and ensuring regulatory compliance. Ideal candidates will...SeniorRegulatory- ...BridgeBio is seeking a Senior Manager, Project Management in San Francisco. This hybrid role involves organizing CMC/QA team activities, managing manufacturing activities with CDMOs... ...a strong project management background in biotech with a focus on effective communication...Senior
$285k - $320k
...excitement... read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early‑stage research... ...clarity, speed, and quality of work. What You’ll Do Lead CMC regulatory strategy and execution across development and post‑approval programs...SeniorRegulatoryFull timeWork at officeRemote workFlexible hours$140k - $214k
...goal to improve medical treatment for patients suffering from immunological diseases. Position Summary Vera is seeking a Senior Manager, Regulatory CMC to join an experienced, fast‑paced and collaborative team. The Senior Manager will report to the Senior Director of...SeniorRegulatory- Dormont Manufacturing Co is seeking a Regulatory Affairs CMC expert to lead submissions and strategy in the biotech industry. The ideal candidate will have extensive experience in regulatory affairs, particularly with NDA/MAA submissions, and strong cross-functional leadership...RegulatoryRemote jobWork at office
- BridgeBio Pharma in California is seeking a Regulatory CMC professional to lead the regulatory strategy for IND, NDA, and MAA submissions. The role requires extensive experience in regulatory affairs within biotechnology and a strong ability to mentor team members. Responsibilities...SeniorRegulatoryRemote jobWork at office
$336k - $405k
A leading biotech company in California is seeking a Vice President of Clinical Development to provide executive leadership in clinical... ...'ll strategically plan clinical development programs, ensure regulatory compliance, and lead cross-functional teams to meet corporate...SeniorRegulatory- Dispatch Bio in San Francisco seeks a Senior Associate in Regulatory Affairs to contribute to the regulatory team. The role involves authoring complex regulatory submissions, managing interactions with health authorities like the FDA, and supporting regulatory strategies...SeniorRegulatoryFlexible hours
$90.2k - $175.1k
...IQVIA Biotech is seeking CRA 2 and Sr. CRA 1 candidates with onsite monitoring experience in oncology. Join a Team That’s Advancing... ...elevate when needed Track and manage study progress, including regulatory approvals, enrollment, and data quality Maintain accurate documentation...SeniorRegulatoryFull timePart timeWorldwide- Senior Manager, Statistical Programming/SAS Programming - San Francisco Tanner and Associates... ...Programming/SAS Programming for a large biotech company based in San Francisco. Full... ...They will provide filing, approval and regulatory programming support for all aspects of a...SeniorRegulatoryRelocation
$175k - $200k
...oncology related diseases. The Senior Protein & Peptide/Chemical‑... ...input into developability and CMC decisions. Key Responsibilities... ...to IND‑enabling and regulatory documentation (CMC sections)... ...IND/IMPD) Prior experience in biotech or fast‑paced development environments...SeniorRegulatory- A top-tier biotech company in San Francisco is seeking a Senior Manager for Clinical Operations. The role involves overseeing clinical trial operations, project... ...lead in a dynamic environment and ensure adherence to regulatory guidelines. #J-18808-Ljbffr TANNER & ASSOC INCSeniorRegulatory
$311k - $388.5k
...Senior Director, Biostatistics New York, NY; Boston, MA; San Francisco, CA; Raleigh... ...companies, research organizations, and biotechs to develop programs past clinical proof... ...shaping innovative trial designs, supporting regulatory strategies, and ensuring high-quality...SeniorRegulatoryWork at officeLocal areaRelocation3 days per week$160k - $175k
...we pioneered a “moneyball for biotech” approach, pooling projects and... ...of work. What You’ll Do The Senior Manager, Project Management will... ...Management, and support the CMC team to ensure that cross‑functional... ...of certain sections of regulatory filing and cross‑functional reviews...SeniorRegulatoryFull timeWork at officeFlexible hours$195.5k - $272.5k
...in San Francisco is looking for a highly motivated Director of Regulatory CMC to ensure regulatory compliance for clinical development and... ...regulatory guidelines, and the ability to effectively present to Senior Management. The expected salary range for this role is $195,50...Regulatory- ...1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest... ...while transforming your career. Senior Scientist - Computational Discovery & Translational... ...‑to‑function inference, incorporating regulatory genomics and epigenomic data to link non...SeniorRegulatoryFlexible hours
$130k - $160k
...We AreWe are the first publicly-traded biotech or pharmaceutical company to take the form... ...)* Adhere to all corporate, external regulatory, and UT guidelines related to the promotion... ...160,000 per year and the salary for the Senior Cardiopulmonary-PAH (CPS) Specialist is...SeniorRegulatoryLocal areaRemote work$230k - $300k
...BIOTHERAPEUTICS Lakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and San... ...The Role We are seeking a Director or Senior Director of Biostatistics to serve as... ..., interpretation of results, and regulatory submission. You will work hand‑in‑hand...SeniorRegulatoryContract workInterim role$162k - $189k
## Senior Scientist IApplylocations: South San Francisco, Californiatime... ...safety, quality, and regulatory requirements.* Apply modern synthetic... ...to develop and execute a CMC strategy that aligns with the... ...related field) with 5+ years of biotech/biopharma industry experience...SeniorRegulatory$200k - $235k
Ray Therapeutics seeks a Director of Regulatory Affairs - CMC based in Berkeley, CA. This leader will develop global regulatory strategies for... ...a strong background in regulatory affairs, specifically in biotech, with at least 10-12 years of experience. A competitive salary...Regulatory$150k - $170k
...We are looking for a talented, motivated Senior Manager to join our Portfolio & Program Management... ...across Operations Technology, Clinical, Regulatory, and other development functions to... ...project management with an emphasis on CMC knowledge and the ability to support Clinical...SeniorRegulatoryFull timeWork at officeLocal areaRemote work$300k - $420k
...with their novel therapeutic platform. They are seeking a Senior Vice President of Regulatory Affairs to oversee all regulatory activities and be... ...organization. Comfortable wearing many hats in a small biotech environment while setting a high bar for rigor, accountability...SeniorRegulatoryLocal areaRelocationFlexible hours3 days per week$93.1k - $232.8k
Company Overview IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer... ...cross-functional teams, and ensure compliance with ICH-GCP, regulatory requirements, and study protocols . This is a highly visible...SeniorRegulatoryFull timeContract workPart timeWork at officeWorldwide$215k - $230k
...California, or remotely. Summary The Senior Clinical Research Scientist II... ...therapies, and support regulatory submissions. Responsibilities... ..., Regulatory, and CMC teams to ensure high-quality study... ...haves Experience in fast paced biotech environment Experience with product...SeniorRegulatoryLocal areaRemote work$154.89k - $176.98k
Senior Science Officer, Preclinical Development The California Institute... ...scientific, technical, regulatory, and operational risks early and... ...Experimental design and data robustness CMC development and... .../translational development in biotech, pharma, or academia Demonstrated...SeniorRegulatoryCasual workWork at officeRemote work$169.22k - $253k
## Senior Medical Science Liaison, Nephrology (Northern California, OR, WA and Alaska)Applylocations... ...medical affairs roles in the pharma/biotech industry or the equivalent combination... ...Strong understanding of industry legal, regulatory, and compliance landscape• Ability to...SeniorRegulatoryTemporary workLive inWork at officeLocal areaFlexible hours- ...ensuring alignment with control strategy and regulatory filings. Serve as the technical lead,... ...manufacturing support Author and review relevant CMC documentation including PV protocols/... ...process development experience in the biotech/biopharma industry; or BS/MS with 12+...RegulatoryContract work
$195.5k - $272.5k
...a highly motivated, self‑driven and enthusiastic Director of Regulatory CMC accountable for ensuring all assigned products have a successful... ...procedures a plus Ability to effectively present to Senior Management WHO WE ARE AND WHAT WE OFFER The expected salary range...RegulatoryFull timeWork at officeWork visa3 days per week$186.62k - $252.49k
...for its Enterprise Lifecycle team. This role involves technical leadership in building critical systems for FDA submissions and regulatory compliance. The ideal candidate has 8+ years of experience, strong backend and API development skills, and is proficient in scalable...SeniorRegulatory$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San Francisco, Californiatime... ...clinical supply chain, CMC, quality, regulatory, program & portfolio management.This... ...and collaborations with other pharma/biotech companies and at the Joint Development...SeniorRegulatory
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