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, CA3 hours 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...SuggestedContract workSentibio
South San Francisco, CA4 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 $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...SuggestedFull time- ...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...SuggestedRemote work
- ...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
$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- ...Executive Director, Regulatory Affairs About the Company Esteemed company developing medicines for inflammatory & autoimmune diseases Industry Biotechnology Type Privately Held, VC-backed Founded 2018 Employees 51-200 Funding...
Confidential
San Francisco, CA2 days ago - ...B Capital sucht einen Principal Regulatory Affairs Specialist für die Einhaltung von Anforderungen im Bereich Medizinprodukte, insbesondere für den Schweizer Markt. In dieser Schlüsselrolle bauen Sie Beziehungen zu nationalen Behörden auf und stellen die regulatorische...
B Capital
San Francisco, CA2 days ago - ...GondolaBio, a clinical-stage biopharmaceutical company, seeks an experienced regulatory affairs leader to drive global strategy for early clinical programs addressing genetic diseases. You will own IND/CTA planning and navigate accelerated pathways, partnering with cross...
GondolaBio
San Francisco, CA4 days ago $193.4k - $241.8k
...hybrid model requires this role to work in our office an average of 3 days per week. Position Summary Join a highly visible Regulatory Affairs team where you'll help shape promotional strategy for innovative therapies while serving as a trusted advisor to cross-functional...Work at officeLocal areaRemote workNight shift3 days per weekACADIA Pharmaceuticals
San Francisco, CA2 days ago$244k - $305k
...Revolution Medicines is seeking a seasoned professional for regulatory management in oncology. The ideal candidate will have over 12 years... .../biotech industry and a minimum of 8 years in Regulatory Affairs. Responsibilities include directing regulatory strategy for late...REVOLUTION Medicines
San Francisco, CA2 days ago$230k - $270k
...inhibits ITK to modulate and control parallel signaling pathways in the immune system. Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of the Regulatory organization, responsible for developing and...Corvus Pharmaceutical
San Francisco, CA2 days ago$160k - $185k
...resistance 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...Odd jobH1bWork at officeORIC Pharmaceuticals Inc
South San Francisco, CA3 days ago- ...Iovance Biotherapeutics, Inc. is seeking a Director of Regulatory CMC to lead one or more drug development programs with emphasis on global strategy, submissions, and Health Authority interactions. The role requires deep understanding of clinical development strategies...
Iovance Biotherapeutics, Inc.
San Carlos, 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...
Erasca, Inc.
South San Francisco, CA2 days ago $240k - $275k
...The International Executive Service Corps is hiring a Director of Clinical Regulatory Affairs to shape and execute the global clinical regulatory strategy. The role involves overseeing clinical submissions and ensuring compliance with regulatory requirements. The ideal...International Executive Service Corps
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$198k - $257k
...the Company has a global team of approximately 2000 employees. Job Description Primary Function: The Associate Director, Regulatory Affairs supports the development and execution of clinical regulatory strategies and regulatory development activities for...Work at officeWorldwideRelocation package$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
San Bruno, CA2 days ago- 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
$240k - $275k
Position Summary The Director, Clinical Regulatory Affairs serves as a senior regulatory leader responsible for shaping and executing the global clinical regulatory strategy across Nektar’s development portfolio. This role oversees end‑to‑end planning and delivery of global...Local area$200k - $250k
...medical need as well as a pipeline to treat both rare and large market indications. Reporting to the Chief Regulatory Officer, the Director, Regulatory Affairs CMC will serve as a key member of the Regulatory organization, responsible for developing and executing global...$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$265k - $285k
...Senior Director, Regulatory Affairs We are seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate...Work at officeRemote workFlexible hoursAnnexon Biosciences
San Francisco, CA2 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 $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
Daly City, CA3 days ago$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...- ...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
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director of Regulatory Affairs. Be the first to apply!
- regulatory affairs manager pharmaceutical South San Francisco, CA
- manager regulatory affairs South San Francisco, CA
- regulatory cmc manager South San Francisco, CA
- regulatory manager South San Francisco, CA
- compliance manager South San Francisco, CA
- compliance director South San Francisco, CA
- director global regulatory affairs South San Francisco, CA
- regulatory & compliance manager South San Francisco, CA
- regulatory affairs director South San Francisco, CA
- head compliance South San Francisco, CA