73 Results for

Regulatory Affairs Jobs in San Anselmo, CA

Jobs

Alameda, CA8 days ago

Remote

$140–$155 Per Hour

Serve as a key cross-functional partner across Research & Development, Quality Assurance, Pharmaceutical Supply Chain, and Information Technology to drive enterprise-wide implementation of regulatory expectations. RequirementsBachelor’s degree in a related discipline with minimum of thirteen years of relevant experience; or master’s degree with at least eleven years; or PhD with at least eight years; or equivalent education and experience.

New!

San Francisco, CA4 days ago

Remote

$183,549–$275,324 Per Year

The current base salary range for this position is expected to be between $183,549 – $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. As a key cross-functional partner, the Medical Director collaborates closely with Commercial, Clinical Development, Regulatory, and Market Access teams, among others, to shape brand and portfolio strategy, integrating real-world evidence and external expert perspectives.

New!

Alameda, CA1 day ago

Remote

$80–$100 Per Hour

Maintain current and complete Trial Master Files (TMF) and Veeva RIM related documents, working with relevant teams. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.

New!

San Francisco, CA4 days ago

Remote

$229,562–$344,342 Per Year

The role oversees a high-impact team and partners cross-functionally and externally to drive an integrated publications and scientific communications strategy, translating complex data into compelling evidence that supports clinical adoption, informs healthcare decision-making, and differentiates the company’s portfolio globally. Agios Pharmaceuticals is searching for a dynamic Senior Director, Global Scientific Communications and Publications expert to join our Global Medical Affairs team and lead a high-functioning communications/publications/congress team.

Fairfield, California24 days ago

Bachelor’s degree in relevant field preferred or equivalent combination of education and experience; minimum of two (2) years’ experience as a Regulatory Affairs Specialist or relevant experience in managed care with knowledge of the Medi-Cal, and NCQA requirements, and preferably Medicare and Knox Keene. Overview: The Regulatory Affairs Specialist II has demonstrated competencies in supporting the plan-wide regulatory affairs and compliance program, including activities related to HIPAA and Fraud, Waste, and Abuse (FWA).

San Francisco, CA14 days ago

This leader serves as the senior clinical authority for NAM education, ensuring programs meet the needs of practicing clinicians while supporting business priorities, product adoption, and long term customer trust. • Oversee planning and execution of clinical educational events (e.g., courses, workshops, symposia, webinars), ensuring end-to-end operational excellence (logistics, faculty coordination, attendee experience) and alignment to learning objectives.

New!

Foster City, CA1 day ago

Responsibilities:Lead integrated CMC planning across Drug Substance, Drug Product, Analytical, Quality, Regulatory, and Supply Chain, aligning deliverables, timelines, and priorities with clinical and regulatory objectives. Develop, maintain, and manage integrated project timelines in Planisware or Smartsheet, clearly defining dependencies, milestones, and critical path activities.

New!

South San Francisco, CA6 days ago

Remote

$170,000–$210,000 Per Year

Reporting to the Senior Director, Regulatory Affairs, this position will serve as a core regulatory representative on cross‑functional program teams, supporting interactions with global health authorities and ensuring regulatory strategies and submissions are aligned with evolving regulatory expectations for cell and gene therapies. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

South San Francisco, CA30+ days ago

$235,000–$260,000 Per Year

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission.

Burlingame, CA30+ days ago

Review significant regulatory issues with manager, as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed. Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level.

Richmond, CA30+ days ago

Full-time

Knowledge of current Good ClinicalPractices (cGCP), current Good Manufacturing Practices (cGMP), Good Documentation Practices and a strong understanding of FDA regulations and guidelines. Participate in review of BabyBIG documentation to support highest possible quality of all records produced by manufacturing contractors or contracting research organizations .

SF, CA30+ days ago

POSITION SUMMARY:The Senior Regulatory Affairs & Compliance Specialist is responsible for ensuring compliance with regulatory, licensing, and contractual requirements set forth by the Centers for Medicare and Medicaid Services (CMS), the California Department of Health Care Services (DHCS), and other regulatory agencies. Seniors, their family members, and caregivers face many issues, including transportation to appointments, management of medications, coordination of medical care from different specialists, lack of social interaction, and ability to stay alone at home.

San Francisco, CA30+ days ago

Summary:This role provides global regulatory leadership and expertise to ensure compliance and successful submission of clinical regulatory filings. The position involves developing regulatory strategies, managing submissions, and maintaining communication with regulatory agencies and project teams.

New!

Alameda, California2 days ago

Remote

$85–$93.68 Per Hour

Collaborate with Quality Assurance and cross‑functional stakeholders to support health authority inspections across GPS and Regulatory Affairs, ensuring the RA function remains in a continuous state of inspection readiness. · Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs-related documents.

Alameda, California9 days ago

$133.33–$153.33 Per Hour

Bachelor's degree in related discipline and a minimum of thirteen years of related experience; or, · Master's degree in related discipline and a minimum of eleven years of related experience; or, · PhD degree in related discipline and a minimum of eight years of related experience; or, · Equivalent combination of education and experience. Leads the systematic collection, analysis, and dissemination of regulatory intelligence to proactively inform our client's policies, processes, and practices, enabling subject matter experts to assess the impact of evolving global regulatory requirements and translate regulatory changes into actionable guidance.

South San Francisco, CA30+ days ago

$276,000–$345,000

Collaborate with cross-functional teams (Clinical Development, CMC, Quality Assurance) to ensure regulatory compliance throughout the development process and ensure cross-functional alignment during key steps across multiple projects simultaneously. We are seeking a strategic and results-oriented leader to oversee all regulatory activities for our hematology/immunology pipeline, with an initial focus on the upcoming Phase 3 clinical trial for our lead candidate, VGA039.

San Francisco, California12 days ago

Remote

$90–$125 Per Hour

Build long-horizon compliance tasks with deterministic rubrics to evaluate agent performance against verifiable ground truth. Proficiency in producing compliance artifacts: policies, risk assessments, training materials, regulatory change memos.

San Francisco, CA30+ days ago

$225,000

Strategic Client Leadership & Outcomes - You will serve as the senior strategic contributor to C-suite and executive leaders within the technology sector, guiding them through complex challenges related to corporate reputation, public affairs, and market positioning. We apply our unique expertise across strategic communications, public affairs, research, and digital marketing to create sophisticated and customized strategies that make change possible for both American and European clients.

San Francisco, CA30+ days ago

$300,000–$360,000 Per Year

Advance collaborations with Key Opinion Leaders and establish robust partnerships within the medical and scientific community, including oversight of KOL interactions, advisory board strategy, academic partnerships, and professional society activities to generate actionable insights. Provide cross-functional leadership and strategic input across clinical development, clinical operations, regulatory affairs, commercial, market access, and pharmacovigilance to inform product development strategies and commercial planning.

Foster City, CA30+ days ago

Utilize data analytics to uncover areas of opportunities with CCC and SEC leadership to enhance performance, efficiency and project management, tracking productivity and operational excellence with key performance indicators (KPIs). This role serves as a strategic partner and operational leader within the US Medical Affairs Oncology organization, supporting CCC (Community Cancer Collective) and SEC (Strategic Evidence and Collaborations) initiatives.

Walnut Creek, CA30+ days ago

$105,000–$115,000 Per Year

You'll play a key role in building our organic certification programs and supporting our partnerships with our CoMan network and major retailers like Walmart and Costco. Most of our work happens in the office to spark creativity and community, but we also offer flexibility so team members have the autonomy to work outside the office when needed to support their work-life balance and personal commitments.

San Francisco, CA30+ days ago

$142,500–$199,000 Per Year

These include the preparation and compilation of submissions for regulatory agencies across assigned clinical studies and programs, management of regulatory submission processes and timelines, and oversight of regulatory tracking tools, archives, and infrastructure. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications.

South San Francisco, CA30+ days ago

Remote

$154,000–$300,000

This model supports scientific entrepreneurs from the initial idea to clinical proof of concept (PoC) by combining a dedicated fund (TCG Labs) with our independent, evergreen R&D center led by a top-tier scientific team (Soleil). The anticipated salary range for fully qualified candidates applying for this role for an Associate Director will be $154,000 - $275,000 annually and for Director will be $168,000 – 300,000 annually (both levels are not including discretionary bonus, equity, and benefits).

New!

San Francisco, CAToday

$125,000–$140,000 Per Year

SFHP is chosen by eight out of every ten San Francisco Medi-Cal managed care enrollees and its 175,000+ members have access to a full spectrum of medical services including preventive care, specialty care, hospitalization, prescription drugs, and family planning services. Established in 1997, San Francisco Health Plan (SFHP) is an award-winning, managed care health plan whose mission is to provide affordable health care coverage to the underserved low and moderate-income residents in San Francisco County.

Berkeley, CA30+ days ago

$220,000–$235,000 Per Year

Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline. The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP, PV, and GLP focused team settings and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies.

South San Francisco, CA30+ days ago

$156,000–$195,000

As an Associate Director, the candidate is expected to represent translational sciences as a translational medicine lead for clinical studies and work closely with the clinical development team members including bioanalysis, clinical operations, regulatory affairs, quality, medical writing, safety, clinical research and clinical leadership. As part of the collaborative research team role, the candidate is expected to work with individuals across research and translational research groups, including discovery research, drug development and protein sciences, preclinical bioanalysis and other junior staff within translational research organization.

Daly City, California30+ days ago

Collaborates with the CNO and directs and participates in the preparation and administration of nursing services, budgets and capital outlay requests; evaluates staffing, equipment and supply needs; prepares justifications and cost benefit analyses; reviews and recommends approval of expenditures; oversees the procurement of supplies and equipment for assigned areas. Conduct on-going surveillance using Center of Disease Control (CDC) infection criteria, documentation, and investigation of nosocomial infections through review of admission diagnoses, microbiology culture results, isolation orders, patient records, consultation requests, post-discharge surveillance, and autopsy findings.

South San Francisco, CA19 days ago

$336,000–$405,000 Per Year

Reporting to the Chief Medical Officer (CMO), the Vice President, Clinical Development provides executive leadership for the company’s clinical research and development activities within designated therapeutic areas and/or programs. The Vice President, Clinical Development serves as a senior leader within Clinical Development, accountable for clinical trial execution, data integrity, regulatory readiness, and cross-functional alignment.

San Francisco, CA16 days ago

$90,000–$105,000 Per Year

South San Francisco, CA8 days ago

Remote

$200,000–$250,000 Per Year

Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. 2+ years experience as a hematology/oncology or cell therapy MSL or similar role within the pharmaceutical or biotech industry or 4+ years experience as a direct patient care provider in a hematology/oncology or cell therapy program.

South San Francisco, CA8 days ago

Remote

$200,000–$250,000 Per Year

Drive Medical Communications (MC) for assigned pipeline assets in partnership with internal stakeholders and external vendors/agencies, including development of the scientific platform and creation/review of scientific communication deliverables (e.g., slide decks, congress materials, FAQs, field medical materials) through MRC review and warehousing. This role will be accountable for defining and executing the global medical information and scientific communications strategy, establishing operational excellence, and ensuring compliant, high-impact scientific exchange aligned with Allogene’s mission to advance allogeneic CAR-T therapies for patients with serious diseases.

San Francisco, CA30+ days ago

Full-time

Vendor ManagementManage the third-party risk management program, ensuring that third-party relationships are adequately assessed for sufficient controls (especially information security), risks and aligned with the credit union’s strategic goals. Today, the San Francisco-based credit union has grown to $1.7B in assets and a membership that extends from the regional firefighters we trace our roots back to throughout our many neighbors in San Francisco, San Mateo and Marin Counties.

New!

South San Francisco, CA1 day ago

Remote

$360,000–$425,000 Per Year

Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease.

San Francisco, CA30+ days ago

$90,000–$100,000

As a trusted third party, we've facilitated over US$7 Billion in secured transactions, including high-profile domain names (like uber.com, snapchat.com, spacex.com, twitter.com, instagram.com), motor vehicles, business acquisitions, electronics and more. Hands-on experience managing one or more core compliance areas, such as transaction monitoring, licensing and renewals, regulatory filings, surety bond renewals, program documentation, or data privacy compliance.

Martinez, CA10 days ago

$91,261–$110,929 Per Year

Four (4) years of increasingly responsible experience in a position with a housing authority or other public or assisted housing agency directly supporting daily housing operations, including two years of demonstrated experience in management of a voucher or Section 8 program another HUD-assisted housing program. Under the direction of the Director of Assisted Housing the Housing Choice Manager is responsible for the overall delivery of the Housing Authority of the County of Contra Costa’s (HACCC) high quality Housing Choice Voucher (HCV) programs within an assigned geographic area of the County of Contra Costa.

South San Francisco, CA30+ days ago

$225,000–$245,000 Per Year

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. Author, review, and manage the development of clinical and regulatory documents, including protocols, investigator brochures, clinical study reports (CSRs), INDs, CTAs, briefing packages, and clinical sections of regulatory submissions.

South San Francisco, CA13 days ago

Remote

$250,000–$335,000 Per Year

Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. Participate in the authoring of relevant safety sections of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF), statistical analysis plans, study reports and other clinical study-related documents to ensure alignment with the safety strategy and risk communication.

South San Francisco, CA30+ days ago

$200,000–$230,000
Full-time

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Oakland, CA30+ days ago

$51.83–$86.39 Per Hour

SUMMARY:The Diagnostic Imaging Education, Quality & Informatics Administrator is a key member of the Diagnostic Imaging leadership team, responsible for providing strategic oversight of department-wide education, clinical competencies, quality assurance, regulatory compliance, PACS/RIS workflow support, and radiologic student training programs. Project Management Professional (PMP) and/or Lean Six Sigma certification (Green Belt or higher) is strongly preferred to support the successful execution of cross-functional initiatives focused on increasing efficiency, reducing variation, and improving quality outcomes across the imaging service line.

New!

San Francisco, CA3 days ago

Remote

$264,000–$290,000 Per Year

The Payor and Health Systems Liaison leads high impact clinical, scientific, and population health engagement with external access stakeholders, including Payers, Group Purchasing Organizations (GPOs), Community Aggregators, and Integrated Delivery Networks (IDNs), while ensuring strong integration between Medical Affairs, HEOR, and Market Access strategy. They will develop and cultivate relationships with key decision-makers and other influencers in managed care organizations, government programs, employers, hospital systems and product distribution companies, to support appropriate patient access and evidence-based utilization for our client’s products.

Alameda, CA30+ days ago

$195,000–$250,000

You will oversee internal and external development partners, manage design control and technology transfer, and collaborate closely with Operations, Quality, Regulatory, and Clinical teams to ensure timely and successful program execution. The Head of Technology Development is a senior technical leader responsible for defining and executing the end‑to‑end technology strategy for Vivani’s device and drug–device combination product portfolio.

Brisbane, California30+ days ago

$224,000–$300,000 Per Year

Business areas supported include: research and development, clinical trials (commercial products and potential pipeline products), medical affairs, market access, corporate communications, global supply chain and quality, manufacturing, commercial sales and marketing to healthcare providers, patients and payers (including U.S. Federal Government), business development, procurement, finance, compliance, and human resources. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.

South San Francisco, CA16 days ago

$268,000–$320,000 Per Year

This role is responsible for shaping and executing customer engagement strategy across in-line products, lifecycle initiatives, and development-stage assets, with direct impact on brand performance, market understanding, and organizational alignment. The role leads a team of field-based marketers and is accountable for building a high-performing organization that delivers consistent, high-impact execution across key customer segments.

New!

South San Francisco, CA4 days ago

Remote

$280,000–$320,000 Per Year

Given the unique complexities of CAR T therapy, this role will play a critical part in addressing site-of-care dynamics, center-of-excellence (COE) networks, single case agreements, and innovative payment models to enable broad access across both academic and community oncology settings. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

South San Francisco, CA30+ days ago

$380,000–$420,000 Per Year

The VP, Clinical Development will join the Senior Leadership Team and provide key strategic leadership for clinical development strategy, planning, and tactical implementation for all clinical development functions. Enterprise leader of program strategy, collaborating in a matrixed working environment with clinical operations, regulatory, clinical pharmacology, research, CMC, and other functions to ensure the success of drug development programs.

South San Francisco, CA30+ days ago

Full-time

The MSL Director leads a team of MSLs responsible for driving clinical practice transformation in IntelliSep customer accounts, engaging with the broader clinical and medical stakeholder community supporting pre-sales discussions, and serving as internal clinical and medical subject matter experts partnering with internal teams to share HCP feedback. Reporting to the Executive Director of Medical & Scientific Affairs, the MSL Director works closely with the internal and external stakeholders to build and execute a coordinated scientific and commercial partnership strategy that enhances account development, increases clinical utilization, and drives successful and effective adoption of IntelliSep clinical workflows.

San Francisco, CA17 days ago

Remote

$268,000–$295,000 Per Year

Demonstrated leadership skills (proactive, strategic, creates a highly accountable team culture, provides clear direction), project management and organizational skills, with the ability to evaluate competing priorities to arrive at an appropriate decision. Oversees execution of stakeholder engagement strategy across regional and community healthcare providers, including academic institutions and community centers across the aligned region to ensure timely and accurate scientific communication.

South San Francisco, CA30+ days ago

$250,000–$280,000

Strategic planning and implementation: Define and lead the global HEOR roadmap for ETX101, ensuring that strategies drive creation of a strong value story for ETX101 to optimize payer and HTA engagement in alignment with clinical, regulatory and commercial readiness timelines and plans. Operational excellence: Manage vendor selection, budgets, and resource allocation for complex HEOR projects, ensuring timely completion and, in concert with Scientific Communications, high-impact delivery of abstracts, posters, and manuscripts.

New!

South San Francisco, California3 days ago

Employee

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Regulatory Affairs Jobs in San Anselmo, CA

Jobs

Temporary Regulatory Affairs Strategy DirectorJoulé

Medical Director, Global Medical Affairs - RemoteAgios Pharmaceuticals

Temporary Senior Manager ComplianceJoulé

Senior Director, Global Scientific Communications and Publications - RemoteAgios Pharmaceuticals

Regulatory Affairs Specialist IIPartnership HealthPlan of California

Senior Director, Clinical Education and EventsDentsply Sirona

CMC Project ManagerIconma

Associate Director, Regulatory AffairsAllogene Therapeutics

Director, Regulatory AffairsSepterna

Medical Devices, Regulatory Affairs SpecialistMeta

Regulatory Affairs CoordinatorPublic Health Foundation Enterprises, In

Snr Regulatory Affairs & Compliance Specialist PACEOn Lok

Director of Regulatory AffairsCEDENT

Regulatory Affairs Quality/Standards/Training Manager - RemoteRoth Staffing Companies

Regulatory Affairs Strategy DirectorRoth Staffing Companies

VP. Regulatory AffairsStar Therapeutics

Compliance Expert - Regulatory AffairsMercor

Managing Director, Public Affairs & Strategic Communications (Technology)Bully Pulpit International

Vice President, Medical AffairsVir Biotechnology

Senior Manager - Medical Affairs*Lancesoft

Sr. Regulatory Documentation Control Specialist - OrganicKinder's

Senior Manager, Regulatory OperationsVir Biotechnology

Associate Director / Director, Quality AssuranceSoleil Labs, LLC

Senior Administrative Contracts ManagerSan Francisco Health Plan

Director of Quality Assurance, ClinicalCaribou Biosciences, Inc.

Associate Director, Translational ScienceStar Therapeutics

ASSOCIATE CNOAHMC Healthcare

Vice President, Clinical DevelopmentRigel Pharmaceuticals, Inc.

Program Manager, NCQASan Francisco Health Plan

Director, Medical Science Liaison (Northeast US and Canada)Allogene Therapeutics

Director, Global Medical Information & Scientific CommunicationsAllogene Therapeutics

Chief Risk Officer (On-site)SF Fire Credit Union

Vice President, Clinical Development (Oncology)Allogene Therapeutics

Compliance Program LeadFreelancer.com

Housing Programs ManagerContra Costa Housing Authority

Director, Medical WritingSepterna

Medical Director, PharmacovigilanceAllogene Therapeutics

Director of QualityJobot

Diagnostic Imgng Educ., Qulty-Infrmtcs Admnstrtr, Full Time, Hybrid, Benefited, Days, 8hrs, 1.0fteAlameda Health System

Senior Director, Payor and Health Systems LiaisonTaylor Strategy Partners

Head of Technical DevelopmentVivani Medical, Inc

Senior Director, Transactional AttorneyPacira Pharmaceuticals, Inc.

Executive Director, Key Customer StrategyRigel Pharmaceuticals, Inc.

Executive Director, Market AccessAllogene Therapeutics

Vice President, Clinical DevelopmentSepterna

Director, Medical Science LiaisonsCytovale

Senior Director, Regional Medical Science LiaisonTaylor Strategy Partners

Senior Director, Global HEOR and Evidence GenerationEncoded Therapeutics

Strategy Insights & Planning Consultant - CRM & Field EngagementZS

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