Senior Manager, Regulatory CMC - Biotech Submissions Lead
$140k - $214kDormont Manufacturing Co
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 have a BA/BS in a scientific field and at least 6 years of relevant experience, with an emphasis on the US regulatory landscape. A competitive salary range of $140,000 to $214,000 USD is offered, reflecting experience and qualifications. #J-18808-Ljbffr Dormont Manufacturing Co
$140k - $214k
...care for patients. Vera Therapeutics’ lead product candidate is atacicept, a... ...Position Summary Vera is seeking a Senior Manager, Regulatory CMC to join an experienced, fast‑paced and... ...team to lead and support regulatory submissions and activities in the US and globally...Senior- 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...SeniorRemote jobWork at office
$285k - $320k
...pioneered a “moneyball for biotech” approach, pooling... ...teams of experts to lead the way. We build bridges... .... What You’ll Do Lead CMC regulatory strategy and execution... ...ensuring high‑quality submissions aligned with global... ...coach, and potentially manage team members as organizational...SeniorFull timeWork at officeRemote workFlexible hours- ...national recruiting company is seeking a skilled Project Manager to oversee project management of drug development processes. Responsibilities include leading cross-functional teams, managing regulatory submissions, and ensuring projects meet business needs. Ideal...Senior
$165k - $195k
...leadership and support to global regulatory activities to achieve... ...of regulatory approvals. Lead preparation, review and submission of INDs/CTAs, amendments,... ...document packages and manage other regulatory activities... ...nonclinical, clinical, and CMC activities, while planning...SeniorHourly payContract workWorldwide$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San Francisco, Californiatime... ...supply chain, CMC, quality, regulatory, program & portfolio management.This role will include direct... ...with other pharma/biotech companies and at the Joint Development...Senior$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for... ...for drug approvals and submissions. Candidates should have extensive... ...Regulatory Affairs CMC within the biotech or pharmaceutical industry and be adept at managing complex global submissions....Remote job$170k - $200k
Kyverna Therapeutics is seeking a Sr Manager/Associate Director of Safety and Pharmacovigilance to join their team in Emeryville... ...relationships, signal detection, and collaboration on regulatory submissions. The ideal candidate will have a strong background in pharmacovigilance...Senior- ...milestones. This role involves developing and executing communication strategies, managing external inquiries, and collaborating across teams. Applicants should have over 10 years in biotech communications, strong project management skills, and a bachelor's degree in a...Senior
- Sutro Biopharma in South San Francisco is seeking a Senior Manager for Regulatory Affairs to provide leadership in global clinical trial applications... ...products. Ideal candidates will have 5-6 years in pharma/biotech, including 4 years in Regulatory Affairs. This role...SeniorWork at office
- A Section Lead (Senior Director-level) position in Analytical Development... ...and develop a team of managers and analysts in biologics... ...including CQA assessments. Support regulatory submissions and Q&A; mentor authors.... ...and cGMP. End‑to‑end CMC and lifecycle understanding...SeniorLocal areaRelocationRelocation package
$119k - $190k
Brave in San Francisco is seeking a (Senior) Manager, Regulatory Affairs to support global regulatory submissions, focusing on EU and ex-U.S. Clinical Trial Applications. With a minimum of 5 years of experience, the ideal candidate will manage CROs and coordinate cross...Senior$205.9k - $382.5k
...Opportunity A Section Lead position, a Senior Director-level role,... ...system strategy, and regulatory filings of multiple projects... ...about 20 composed of managers, analytical leads,... ...Support regulatory submissions and Q&A and provides... ...cGMP. End-to-End CMC and lifecycle understanding...SeniorLocal areaRelocation package$275k - $280k
...that enable people to lead longer and healthier lives... ...: The Director of Regulatory CMC will lead the... ...approval supplements Submissions and Document Leadership... ...other major markets ~ Manage the lifecycle of the Common... ...stakeholders and senior leadership and externally...- ...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
$119k - $190k
...cardiovascular diseases. Our lead product candidate,... .... The role: The (Senior) Manager, Regulatory Affairs will be a key... ...’s global regulatory submissions, with a primary focus... ...a fast‑paced, lean biotech environment. Key responsibilities... ...Collaborate with CMC and Quality teams to...SeniorFlexible hours- Senior Manager, Regulatory Affairs Position Overview Sutro has a unique capability... .... Contributes and/or leads regulatory department initiatives... ..., review, and planning of submissions to regulatory agencies... ...experience in pharmaceutical/biotech with minimum 4 years in Regulatory...SeniorWork at office
$218.06k - $327.09k
Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs The Senior Director, Oncology... ...Affairs, leads the development and... ...stage through BLA submission. May serve in dual... ...emerging markets, RA CMC, Labeling and... ...and update senior management on project risks/...SeniorHourly payTemporary workWorldwideFlexible hours3 days per week$195.5k - $272.5k
...looking for a highly motivated Director of Regulatory CMC to ensure regulatory compliance for... ...a record of successful regulatory submissions. This position requires a strong... ...the ability to effectively present to Senior Management. The expected salary range for this role...$235k - $285k
...become the industry-leading G protein-... ...motivated Director/Senior Director of Regulatory Affairs to lead... ...regulatory plans and submissions to support... ...to a fast-paced biotech environment. This... ...authority inquiries. Manage interactions... ...Partner with CMC, Nonclinical,...SeniorFull time- 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...Remote jobWork at office
- F. Hoffmann-La Roche AG seeks a Senior Principal Statistician to provide strategic leadership... ...with cross-functional teams to ensure regulatory compliance and scientific integrity. The... ...within the pharmaceutical or biotech sectors. Strong knowledge of SAS, R, and...Senior
$195.5k - $272.5k
...enthusiastic Director of Regulatory CMC accountable for... ...successful regulatory submissions that demonstrates core... ...department to plan and lead high quality regulatory... ...CMC specific issues Manage CMC regulatory changes... ...effectively present to Senior Management WHO WE ARE...Full timeWork at officeWork visa3 days per week- 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... ...years of project management experience in the biotech or pharmaceutical industry. Key...Senior
- ...is seeking a Principal Scientist PKDM in South San Francisco to lead the Pharmacokinetics and Drug Metabolism team. This role involves... ..., emphasizing collaboration and innovation within a premier biotech environment dedicated to improving patient lives. #J-18808-Ljbffr...SeniorFlexible hours
- Senior Principal Statistician A healthier future drives... ...clinical pipeline and regulatory success.... ...methodological communities. Lead statistical design and... ...within the pharmaceutical, biotech, or healthcare sector.... ...plans and regulatory submissions. Strong expertise in advanced...SeniorLocal area
$115k - $121k
Epic Bio is seeking a Senior Clinical Research Associate in South... ...trials and ensure compliance with regulatory requirements. The ideal... ...in clinical research within a biotech or pharmaceutical environment... ...organizational skills, and the ability to manage multiple priorities. This...Senior$147k - $191k
...founded on the collaboration of leading scientists, industry experts,... ...Lead internal large molecule CMC-focused mass spectrometry and... ...therapeutics within the biotech/biopharma industry (MS with 8... ...successful health authority submissions. Strong grasp of statistical...SeniorLocal area$151k - $196k
A leading biotechnology company is seeking an SEC Reporting and SOX Senior Manager based in South San Francisco, California. In this role, you will lead SEC filing preparations, manage SOX compliance, and enhance financial reporting processes. You should have a bachelor...Senior$120k - $180k
BlackCube Labs in San Francisco is seeking a motivated Tax Manager to oversee income tax provisions and compliance. This role entails leading quarterly and annual tax processes, collaborating with auditors, and ensuring adherence to ASC 740. The ideal candidate will have...SeniorFull time
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