Director of Regulatory Affairs
Enigma Search
Are you a seasoned Regulatory Affairs professional ready to make a significant impact on human health? We are seeking a strategic and driven Director of Regulatory Affairs to join a pioneering research and development company focused on extending healthy lifespan. This is an exceptional opportunity to play a pivotal role in developing and implementing innovative regulatory strategies for groundbreaking programs. You will collaborate with cross-functional teams and external partners, driving regulatory success from IND-enabling studies through clinical proof-of-concept and beyond. Your Impact Develop and execute global regulatory strategies for assigned programs, including first-in-class therapies and programs with external partnerships. Lead interactions with global health authorities, preparing briefing packages and ensuring clear communication. Collaborate with executive leadership to define regulatory strategies aligned with the company\'s mission. Oversee the preparation and submission of regulatory applications, ensuring accuracy and timeliness. Develop effective CMC regulatory strategies in collaboration with Technical Operations. Provide strategic regulatory input to development teams, protocols, reports, and other critical documents. Stay ahead of global regulatory changes, communicating updates and developing proactive strategies. Collaborate with cross-functional teams and external consultants. What You Bring Minimum of 10 years of regulatory affairs experience in industry, academia, or clinical research, with experience in rare disease development and/or novel endpoints. Proven track record of developing regulatory submissions, including experience with major approvals (NDA, BLA, MAA, etc.). Strong knowledge of global regulations (FDA, EMA, etc.). Experience with mechanisms to expedite agency interactions. Advanced skills in creating and assessing regulatory proposals and leading health authority interactions. Excellent communication and influencing skills. Self-motivated, strategic thinker with strong problem-solving skills. Exceptional organizational and prioritization skills. Ability to thrive in a fast-paced, collaborative, start-up environment. Must be willing to work onsite at least four days per week. ($275,000-$280,000 base with 25% annual bonus AND $125,000 annual CASH bonus) #J-18808-Ljbffr
$200.7k - $234.15k
## Associate Director, Regulatory AffairsApplyremote type: Hybridlocations: South San Francisco, Californiatime type: Full timeposted on: Posted... ...dysfunction.Reporting to the Executive Director, Regulatory Affairs, the Associate Director, Regulatory Affairs, is responsible...SuggestedCytokinetics
South San Francisco, CA7 hours ago$220.6k - $275.7k
...three days per week on average. Position Summary The Senior Director, Regulatory Operations provides strategic and operational leadership for... .... This role is a key member of the Global Regulatory Affairs Leadership Team and plays a critical role in driving operational...SuggestedFull timeWork at officeLocal areaRemote workWorldwideNight shift3 days per week$160k - $185k
...mechanisms. ORIC has offices in South San Francisco and San Diego, California. Job Description We are seeking a motivated Regulatory Affairs professional to join our team and help advance the clinical development of oncology products at ORIC. In this role, you will...SuggestedOdd jobH1bWork at officeORIC Pharmaceuticals Inc
South San Francisco, CA2 days ago- ...Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials. The role involves preparing CMC documents, ensuring regulatory compliance, and coordinating global submissions. The ideal candidate...Suggested
Erasca, Inc.
South San Francisco, CA2 days ago - ...Corvus Pharmaceutical, a clinical-stage biopharmaceutical company in South San Francisco, is seeking a Director of Regulatory Affairs CMC to lead global CMC regulatory strategies across clinical programs and lifecycle. You will partner with CMC, Technical Operations,...Suggested
Corvus Pharmaceutical
South San Francisco, CA2 days ago $175k - $205k
...Sr Manager/Assoc Director, CMC Regulatory Affairs San Diego, CA, South San Francisco, CA or remote Erascais a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs...Temporary workCasual workLocal areaRemote workWorldwideFlexible hoursErasca, Inc.
South San Francisco, CA2 days ago$210k - $240k
...Francisco and backed by venture investors including Y Combinator and Khosla Ventures, among others. About the Role As Director of Regulatory Affairs , you will own and execute ZBiotics’ U.S. and international regulatory and policy strategy. You will help define the pathways...Work at officeLocal areaHome officeFlexible hoursDay shiftZBiotics
San Francisco, CA5 days ago$245k - $285k
...The successful candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading regulatory CMC strategies and activities for a complex cell therapy product on a global basis. The successful candidate...Contract workSentibio
South San Francisco, CA4 days ago$159k
...enterprise policies and external/internal regulatory requirements. It partners cross-... ...Regulatory, analytical, communications or public affairs related position Electric industry... ...information or supervision of a manager or director Ability to analyze complex problems...Contract workWork experience placementWork at officeFlexible hours2 days per week3 days per weekPG&E Corporation
Millbrae, CA2 days ago- ...information at Job Purpose / Summary We seek an experienced Regulatory professional to manage regulatory activities associated with pipeline... ...team and CMOs. This position reports into the SVP Regulatory Affairs and Quality Assurance. The candidate must be able to interpret...Remote work
- Director of Regulatory Affairs | Job Description About ZBiotics At ZBiotics, we make genetically engineered probiotics that improve daily life. As a group of motivated, yet down-to-earth people, we are fueled by two things: a love for science and a commitment to being...Day shift
$275k - $280k
Position Description Calico is seeking a Regulatory Director that will be responsible for, in collaboration with development partners as applicable... ...effective CMC regulatory strategies Represent Regulatory Affairs on development teams and support development teams in...Full time$243k - $299k
...Therapeutics is recruiting a Compliance Counsel, reporting to the Senior Director, Healthcare Law and Compliance. This role will play a pivotal... ...organization’s commitment to ethical business practices, and regulatory compliance as we prepare for our first potential commercial...Work experience placementWork at officeLocal areaFlexible hours3 days per weekDenali Therapeutics
South San Francisco, CA4 days ago- ...Director, Regulatory Affairs Position Title: Director, Regulatory Affairs (Strategy, Immunology and Inflammation) Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation...For contractorsWork at office
$60k - $90k
Job Description At Norton Rose Fulbright, people thrive because of a shared commitment to quality, unity and integrity. The highly regarded law firm consistently receives recognition from Great Place to Work and Top Workplaces, two companies that specialize in assessing...Full timeFor contractorsWork at officeRemote workWorldwideFlexible hoursNorton Rose Fulbright
South San Francisco, CA3 days ago- ...Regulatory Affairs Associate The Regulatory Affairs Associate (RAA) assists other members of Regulatory Affairs Management (RAM) in obtaining and maintaining licenses and applications in accordance with agreed regulatory strategy and AstraZeneca standards. Accountabilities...
AstraZeneca
South San Francisco, CA5 days ago - ...programs along with policies, procedures, business practices, and guidelines that are compliant with state and federal laws and regulatory requirements. Oversee the team accountable for policy, training, compliance advisory services, compliance funding review of grants...Fixed term contractWork at officeLocal areaRemote workRelocation package
ACC San Diego - Association of Corporate Counsel
South San Francisco, CA3 days ago $285k - $320k
...clarity, speed, and quality of work. WHAT YOU'LL DO Lead CMC regulatory strategy and execution across development and post-approval... ...required; advanced degree preferred * Extensive Regulatory Affairs CMC experience within the biotechnology and/or pharmaceutical...Full timeWork at officeRemote workFlexible hours$275k - $280k
...and enable medical breakthroughs. Position Description The Director of Regulatory CMC will lead the development and execution of global CMC... ...with at least 7 years focused specifically on CMC Regulatory Affairs Successful track record of contributing to at least one...$35k - $48k
Clearance Required: Public Trust Education Required: BA/BS US Citizenship: Required Summary The MIL Corporation seeks a Junior Compliance Officer (Operations, Jr. Analyst) to support a federal law enforcement client with I9 audit support services and worksite enforcement...Full timeContract workFor contractorsWork at officeRemote workWeekend workThe MIL Corporation
South San Francisco, CA5 days ago$226.19k - $292.71k
...the lives of patients for generations to come. As the Senior Director - U.S. Ethics & Compliance Advisor (HIV), you will act as the... ...in pratices related to interactions between commercial, medical affairs and market access. Invest time and effort in building strong...For contractorsLocal areaGilead Sciences
Foster, CA1 day ago$169.88k
At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities, collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored...Full timeLocal area$145k - $160k
About Mytra: We're creating an entirely new way to solve the most ubiquitous problem in industry - moving and storing material. We're applying robotics and distributed software to create a new class of product for this $1T market. We're focused on the supply chain...Work at officeMytra
Brisbane, CA1 day ago- Job Description At EisnerAmper, we look for individuals who welcome new ideas, encourage innovation, and are eager to make an impact. Whether you're starting out in your career or taking your next step as a seasoned professional, the EisnerAmper experience is one-of-a-...Local area
EisnerAmper
South San Francisco, CA1 day ago $164k - $226k
...change and overcoming obstacles. The opportunity We’re hiring a Compliance Director to own a major pillar of Altruist’s compliance program spanning Marketing Compliance, Third-Party RIA Regulatory Requests, and Employee Compliance — including licensing and registration,...Work at officeImmediate startShift work3 days per weekAltruist
San Francisco, CA14 hours ago- ...Inc. is seeking an experienced and highly motivated Compliance Director to lead our Affordable Housing Compliance Department. The... ...reviews, physical inspections, and reporting requirements. Monitor regulatory changes and implement operational updates to maintain...Work at officeLocal area
Bell Properties Inc
San Francisco, CA14 hours ago $65 - $77 per hour
This range is provided by ALOIS Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $65.00/hr - $77.00/hr Direct message the job poster from ALOIS Solutions On a mission to assist candidates in...Contract workWorldwideALOIS Solutions
San Francisco, CA5 days ago$210.38k - $272.25k
...improving the lives of patients for generations to come. As the Director, Global Trade Compliance at Gilead you are responsible for... ...a critical connector across Legal, Tax, and Finance, ensuring regulatory compliance, financial integrity, and optimized trade execution...Contract workFor contractorsLocal areaGilead Sciences
Foster, CA2 days ago$156k - $193k
...whether risk scores reflect reality, identify risks that automated systems miss entirely (e.g., emergent social engineering tactics, regulatory shifts, insider collusion patterns), and ensure accountability for remediation. Develop and stress-test risk assessment standards...Work experience placementCasual workLive inWork at officeRemote workShift workVisa Hunt
San Francisco, CA2 days ago- ...Upstart is looking for a Director, Compliance & Controls — Growth to lead compliance and controls for its growth functions in San Mateo... ...requires 7+ years of experience in consumer lending and deep regulatory knowledge. The ideal candidate will oversee compliance for...Remote work
UpStart
San Mateo, CA2 days ago
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