General Manager LUV Car WashGeneral ManagerRohnert Park, CA$63,000–$68,000 / yearThe General Manager (GM) is responsible for all site operations including recruiting of staff, site safety, facilities management, customer service, driving sales, site compliance and the development of the car wash team. Partner with Facilities to ensure all equipment is properly maintained, safely operated and maintenance requests are fulfilled in a timely manner to minimize site downtime.
NewRegional Director - Anesthesiology - Vituity Practice Management - Emeryville VituityRegional Director - Anesthesiology - Vituity Practice Management - EmeryvilleEmeryville, CACommit to creating and demonstrating inclusivity within Vituity including codesigning, building, and executing strategies, policies, and practices that cultivate equity, inclusion, and fair opportunity for all; demonstrating preparedness to educate, mitigate, coach, and address daily bias and exclusion in partnership with the site leadership. Accountable for ensuring meaningful integration occurs: Identify opportunities for practice line integration to ensure the quality and efficiency of patient care delivery across the acute care continuum; assist with new service line startups; engage regularly with integrated site RDs.
Regulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerSan Francisco, CAThis role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
Policy & Regulatory Affairs Manager Zoox IncPolicy & Regulatory Affairs ManagerFoster City, CA$137,000–$187,000 / yearThe Policy and Regulatory Affairs at Zoox is a cross-functional organization responsible for advancing Zoox's public policy, regulatory, and political goals, including working with state regulatory agencies, legislators, executive branch, and policymakers. Exceptional project management and organizational skills, with experience successfully supporting the execution of multiple complex, cross-functional projects simultaneously.
Regulatory Affairs Manager - International Compliance Operations – Diabetes Care (on-site) AbbottRegulatory Affairs Manager - International Compliance Operations – Diabetes Care (on-site)Alameda, CaliforniaLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders.
Regulatory Affairs Manager – APAC - Diabetes Care (on-site) AbbottRegulatory Affairs Manager – APAC - Diabetes Care (on-site)Alameda, CaliforniaYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
Regulatory Affairs Manager - APAC - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Manager - APAC - Diabetes Care (on-site)Alameda, CA$114,000–$228,000 / yearYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager - APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
NewDirector of Regulatory Affairs and Policy SupplyBank.orgDirector of Regulatory Affairs and PolicyOakland, CA$115,000–$130,000 / yearThrough partnerships with global supply chains and community organizations, SupplyBank.org provides a highly cost-effective and scalable mechanism for bulk purchasing and efficiently distributing necessary health, education, and emergency supplies to children, families, and communities that need them throughout California. Of the total 100 acres, more than 80 will be revitalized park spaces, infrastructure improvements and nature based solutions to restore tidal wetlands, habitat, flood management and increase public enjoyment of the Bay Trail and parklands.
Policy & Regulatory Affairs Manager ZooxPolicy & Regulatory Affairs ManagerFoster City, CAThe Policy and Regulatory Affairs at Zoox is a cross-functional organization responsible for advancing Zoox's public policy, regulatory, and political goals, including working with state regulatory agencies, legislators, executive branch, and policymakers. The Policy and Regulatory Affairs Manager will support Zoox’s state policy portfolio, providing important project management, public policy analysis, and help to implement Zoox’s state policy strategy.
Regulatory Affairs Quality/Standards/Training Manager - Remote Roth Staffing CompaniesRegulatory Affairs Quality/Standards/Training Manager - RemoteAlameda, CaliforniaRemote$85–$93.68 / hourCollaborate 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.
NewRegulatory Affairs Manager – Diabetes Care (on-site) AbbottRegulatory Affairs Manager – Diabetes Care (on-site)Alameda, CaliforniaAs a member of the U.S. Regulatory Affairs management team, the successful candidate will lead and develop talent, shape regulatory strategy, and partner across functions to bring innovative products to market, whilst driving regulatory excellence for the manufacture, change management, and ongoing supply of the Libre portfolio. Drive and provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions, 510(k), PMA, and post-market activities.
Senior Manager, Regulatory Affairs - Lingo (on-site) Abbott LaboratoriesSenior Manager, Regulatory Affairs - Lingo (on-site)Alameda, CA$130,700–$261,300 / yearOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance.
Manager, Regulatory Affairs Jade BiosciencesManager, Regulatory AffairsSan Francisco, CaliforniaRemote$135,000–$150,000 / yearJade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Participate in the review of key clinical and nonclinical documents (protocols, IBs, CSRs, DSURs, etc.) to ensure alignment with regulatory obligations and relevant guidelines (ICH, FDA, EMA, ROW).
Associate Director, Regulatory Affairs Advertising and Promotion Mirum Pharmaceuticals IncAssociate Director, Regulatory Affairs Advertising and PromotionFoster City, CA$205,000–$225,000 / yearEducation /Experience: Bachelor's or advanced degree in a scientific discipline, with a minimum of 8 years in Regulatory Affairs with a minimum of 6 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products. Manage and author commercial regulatory submissions, working closely with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
Associate Director, Regulatory Affairs Advertising and Promotion Mirum PharmaceuticalsAssociate Director, Regulatory Affairs Advertising and PromotionFoster City, CaliforniaManage and author commercial regulatory submissions, working closely with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP). Bachelor’s or advanced degree in a scientific discipline, with a minimum of 8 years in Regulatory Affairs with a minimum of 6 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products.
Senior Director, Regulatory Affairs Policy, Regulatory Intelligence & Compliance Exelixis IncSenior Director, Regulatory Affairs Policy, Regulatory Intelligence & ComplianceAlameda, CAThe position oversees the surveillance, triage, interpretation, and dissemination of global regulatory intelligence across Research & Development (R&D), Quality (QA), Information Technology (IT) and Pharmaceutical Supply Chain (PSC), partnering with cross-functional subject matter experts to ensure impact assessments are conducted and documented. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: BA/BA degree in related discipline and 15 years of related experience; or, MA/MA degree in related discipline and 13 years of related experience; or, PhD in related discipline and 12 years of related experience; or, Equivalent combination of education and experience.
Regulatory Affairs Coordinator Public Health Foundation Enterprises, InRegulatory Affairs CoordinatorRichmond, CAFull timeKnowledge 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 .
Director of Regulatory Affairs and Communication Contra Costa CountyCADirector of Regulatory Affairs and CommunicationMartinez, CA$147,558.98–$179,358.86 / yearThe Director of Regulatory Affairs and Communication (RAC) at Contract Costa Health Plan (CCHP or "Plan") is a senior leadership role responsible for leading regulatory oversight, agency communications, Policy Management Program, regulatory audit support, and enterprise regulatory strategy. This role serves as the primary liaison with state and federal regulators, including the California Department of Health Care Services (DHCS), Department of Managed Health Care (DMHC), and Centers for Medicare & Medicaid Services (CMS).
Senior Manager Regulatory Affairs contract Alumis IncSenior Manager Regulatory Affairs contractSouth San Francisco, CA$165,000–$195,000 / yearEDUCATION/EXPERIENCE/SKILLS: Bachelor's or advanced degree in scientific discipline, with a minimum of 5 years of experience working in drug development in the biopharmaceutical industry and at least 3 years of experience in Regulatory Affairs; immunology or rare disease/ orphan drug development experience desirable. We are seeking an exceptionally motivated individual to provide leadership and support to global regulatory activities to achieve Alumis' strategic vision in obtaining worldwide approvals to market our products.
Senior Regulatory Affairs Director - Oncology Cell & Gene Therapy AstraZeneca PlcSenior Regulatory Affairs Director - Oncology Cell & Gene TherapySouth San Francisco, CA$218,058.40–$327,087.60 / yearWorking with colleagues across locations, therapy areas and external partners, this role offers the chance to influence strategy end-to-end, from early development through rapid global approvals, while learning from leading experts, sharing best practices and using data, technology and modern approaches to reduce barriers for patients worldwide. Competitive salary and benefits package on offer: Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
Associate Director, Regulatory Affairs Project Planning & Coordination Acadia Pharmaceuticals IncAssociate Director, Regulatory Affairs Project Planning & CoordinationSan Francisco, CA$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
Senior Program Director (Commercial Regulatory Affairs, Fully Remote) Dawar Consulting, Inc.Senior Program Director (Commercial Regulatory Affairs, Fully Remote)South San Francisco, CARemoteYou will lead Promotional Review Committees (PRCs), review and approve advertising and promotional materials, and partner closely with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA‑compliant communications. Our client, a world leader in biotechnology and life sciences, is seeking a " Senior Program Director, Commercial Regulatory Affairs ".
(Senior) Manager, Regulatory Affairs Braveheart Bio(Senior) Manager, Regulatory AffairsSan Francisco, CaliforniaOur lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Reporting into the Vice President of Regulatory Affairs, this individual will manage the CRO(s) responsible for preparing CTAs, as well as coordinate preparation of cross‑functional deliverables and manage health authority queries and responses.
Director, Regulatory Affairs Nurix Therapeutics IncDirector, Regulatory AffairsBrisbane, CAThis role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix's investigational and marketing applications.
SENIOR MANAGER, REGULATORY AFFAIRS Sutro Biopharma IncSENIOR MANAGER, REGULATORY AFFAIRSSouth San Francisco, CA$153,000–$175,000 / yearPosition Overview: Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in the oncology and auto-immune disease space. Sutro is advancing a robust early-stage pipeline of novel exatecan and dual-payload antibody drug conjugates (ADCs), coupled with high-value collaborations and industry partnerships, which validate its continuous product innovation.
Senior Program Director, Commercial Regulatory Affairs Compass ConsultingSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAProgram Directors in CORA chair Program Review Committees (PRCs) for their assigned responsibilities, e.g., products within a designated therapeutic area(s) or cross-portfolio activities, such as managed care, interactive marketing, etc. Program Directors lead and manage the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion regulatory review and approval for Roche pharmaceutical products.
Senior Program Director, Commercial Regulatory Affairs LancesoftSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$129.714 or more years previous experience leading large-scale, cross-functional project teams or other forums in design, development and implementation of policies, programs or projects with significant organizational impact strongly preferred. Senior Program Directors may be assigned responsibilities for leading complex product launches, combination product PRCs, departmental programs, projects or other deliverables with limited direction.
Director of Regulatory Affairs Epia NeuroDirector of Regulatory AffairsAlameda, CaliforniaAs a Director of Regulatory Affairs you will report to the Chief Executive Officer and be responsible for owning the regulatory strategy and execution end-to-end from early FDA engagement through IDEs and PMA submission and approval, and commercialization. We’re looking for a Director of Regulatory Affairs for our office in Alameda, California who wants to lead, develop and execute the regulatory strategy for Epia Neuro’s Class III implantable neurotechnology.
Manager, Regulatory Affairs iRhythmManager, Regulatory AffairsSan Francisco, CaliforniaRemoteLead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist.
Manager, Regulatory Affairs iRhythm Holdings IncManager, Regulatory AffairsSan Francisco, CARemote$127,000–$165,000 / yearLead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist.
Senior Program Director, Commercial Regulatory Affairs SGA Inc.Senior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAResponsibilities : Commercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for the firm's global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).
NewSenior Manager, Regulatory Affairs - Lingo (on-site) AbbottSenior Manager, Regulatory Affairs - Lingo (on-site)Alameda, CaliforniaOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance.
Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)Alameda, CAIf you provide content to customers through CloudFront you can find steps to troubleshoot and help prevent this error by reviewing the CloudFront documentation. Generated by cloudfront CloudFront Request ID: HApWOKJEzq0IQxi15tNrlpXMJkFtE7qhBCo6PVler_t91rUjMytuOw.
Staff Regulatory Affairs Specialist Procept Biorobotics CorpStaff Regulatory Affairs SpecialistCAWhat Your Day-To-Day Will Involve: Act as a lead regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.
Director, Regulatory Affairs Advertising & Promotion Acadia Pharmaceuticals IncDirector, Regulatory Affairs Advertising & PromotionSouth San Francisco, CA$193,400–$241,800 / yearThe position partners closely with cross-functional teams to support the timely approval and distribution of promotional and disease state materials, serves as the primary liaison with the FDA''s Office of Prescription Drug Promotion (OPDP) for advertising and promotional submissions, and contributes to labeling strategies for regulatory submissions across Acadia''s product portfolio. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.
Senior Director, Regulatory Affairs (Oncology) Exelixis IncSenior Director, Regulatory Affairs (Oncology)Alameda, CA$248,000–$352,500 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in related discipline and a minimum of fifteen years of related experience; or, Master's degree in related discipline and a minimum of thirteen years of related experience; or, PhD degree in related discipline and a minimum of twelve years of related experience; or, Equivalent combination of education and experience. Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
Director, CMC Regulatory Affairs Vir Biotechnology IncDirector, CMC Regulatory AffairsSan Francisco, CA$195,500–$272,500 / yearVir Biotechnology is seeking an a highly motivated, self-driven and enthusiastic Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and commercialization. Manage CMC regulatory changes throughout the product life cycle, including support for relevant quality systems related to change control, discrepancy management, as well as Health Authority inspection support (as applicable).
Director, CMC Regulatory Affairs Vir BiotechnologyDirector, CMC Regulatory AffairsSan Francisco, CA$195,500–$272,500 / yearVir Biotechnology is seeking an a highly motivated, self-driven and enthusiastic Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and commercialization. Manage CMC regulatory changes throughout the product life cycle, including support for relevant quality systems related to change control, discrepancy management, as well as Health Authority inspection support (as applicable).
Manager, Regulatory and Market Affairs Pattern Energy Group IncManager, Regulatory and Market AffairsSan Francisco, CA$103,000–$138,000 / yearA key function of this role will be to identify, research, analyze, and synthesize the cross section of regulatory and wholesale market rules impacting Pattern's existing and planned assets in WECC, MISO, ERCOT, SPP, PJM and other priority markets as needed. Importantly, the role will support the coordination with expert consultants and internal SMEs to clearly and regularly identify and lead Pattern's engagement in regulatory and market design changes, develop Pattern's positions and execute on strategies to achieve desired objectives.
Vice President, Regulatory Affairs, Quality Assurance & Quality Control Venus Concept IncVice President, Regulatory Affairs, Quality Assurance & Quality ControlCA$200,000–$225,000 / yearWe have an exciting opportunity for a highly experienced, strategic, and performance driven Vice President, Regulatory Affairs, Quality Assurance & Quality Control to join our senior leadership team. The successful candidate will be a seasoned executive who has operated at a Vice President level for a minimum of 3 years, with demonstrated experience leading global, regulated medical device organizations.
Regulatory Affairs Strategy Director Roth Staffing CompaniesRegulatory Affairs Strategy DirectorAlameda, California$133.33–$153.33 / hourBachelor'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.
Vice President, Regulatory and Head of Regulatory Affairs Sagimet Biosciences IncVice President, Regulatory and Head of Regulatory AffairsSan Mateo, CA$340,000–$370,000 / yearThis role will serve as the primary liaison with global regulatory authorities and involve close collaboration with Sagimets cross-functional teams and external partners, to ensure the successful advancement of our clinical programs. Oversee the companys external regulatory advisors, consultants and vendors to ensure that relevant regulatory advice is provided with respect to the companys development programs.
Associate Regulatory Affairs Strategy Director (Oncology) Exelixis IncAssociate Regulatory Affairs Strategy Director (Oncology)Alameda, CA$195,000–$277,500 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in related discipline and a minimum of eleven years of related experience; or, Master's degree in related discipline and a minimum of nine years of related experience; or, PhD degree in related discipline and a minimum of five years of related experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: Knowledge/Skills: Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results.
Manager, Regulatory and Market Affairs Pattern Energy Group LPManager, Regulatory and Market AffairsSan Francisco, California$103,000–$138,000 / yearA key function of this role will be to identify, research, analyze, and synthesize the cross section of regulatory and wholesale market rules impacting Pattern’s existing and planned assets in WECC, MISO, ERCOT, SPP, PJM and other priority markets as needed. Importantly, the role will support the coordination with expert consultants and internal SMEs to clearly and regularly identify and lead Pattern’s engagement in regulatory and market design changes, develop Pattern’s positions and execute on strategies to achieve desired objectives.
NewAssociate Director, Regulatory Affairs (on-site) AbbottAssociate Director, Regulatory Affairs (on-site)Alameda, CaliforniaThe individual will play a critical role in anticipating and influencing evolving regulations and guidance, lead complex management change initiatives, interface with outside regulatory agencies and trade associations, and advise executive management with strategic insights and key regulatory metrics. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Associate Director, Regulatory Affairs (on-site) Abbott LaboratoriesAssociate Director, Regulatory Affairs (on-site)Alameda, CA$148,700–$297,300 / yearThe individual will play a critical role in anticipating and influencing evolving regulations and guidance, lead complex management change initiatives, interface with outside regulatory agencies and trade associations, and advise executive management with strategic insights and key regulatory metrics. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Senior Director, Regulatory Affairs CMC Mirum Pharmaceuticals IncSenior Director, Regulatory Affairs CMCFoster City, CA$280,000–$310,000 / yearThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Regulatory Affairs CMC team within the Regulatory Affairs department and across the organization. Actively seeks out knowledge of overall corporate planning, business objectives, and current regulatory requirements to develop regulatory positions for assets in Mirum portfolio, and incorporates this knowledge into submission planning.
Director/Senior Director, Regulatory Affairs SepternaDirector/Senior Director, Regulatory AffairsSouth San Francisco, CA$235,000–$285,000 / yearSepterna 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.
Senior Director, Regulatory Affairs CMC Mirum PharmaceuticalsSenior Director, Regulatory Affairs CMCFoster City, CaliforniaThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Regulatory Affairs CMC team within the Regulatory Affairs department and across the organization. Actively seeks out knowledge of overall corporate planning, business objectives, and current regulatory requirements to develop regulatory positions for assets in Mirum portfolio, and incorporates this knowledge into submission planning.
Sr. Director, Regulatory Affairs BridgeBio Pharma IncSr. Director, Regulatory AffairsSan Francisco, CA$285,000–$320,000 / yearThe ideal candidate brings deep Regulatory CMC expertise, strong cross-functional leadership skills, demonstrated experience with global and ROW filings (e.g., MENA, LATAM, APAC), and practical fluency leveraging AI-enabled and digital tools to improve regulatory workflows and deliverables. Demonstrated experience leading complex global regulatory submissions, including Rest of World (ROW) regions (e.g., MENA, LATAM, APAC), with ability to navigate regional regulatory requirements and coordinate cross-regional filing strategies.