Senior Regulatory PM Lead for IND/CTA to NDA
Denali Therapeutics
Denali Therapeutics is seeking an Associate Director, Regulatory Project Manager in South San Francisco to drive regulatory timelines, coordinate cross-functional teams, and manage risk across IND/CTA-to-BLA/NDA pathways. The role requires senior PM experience, ability to influence stakeholders, and mentoring of junior staff within Regulatory Affairs. Denali offers a competitive compensation package and comprehensive benefits. #J-18808-Ljbffr Denali Therapeutics
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory PM Lead for IND/CTA to NDA in South San Francisco, CA vacancy
- Zai Lab Limited seeks an Associate Director of Regulatory Affairs for onsite work in South San Francisco. This role leads regulatory strategy and execution for clinical programs, coordinating IND submissions and health authority interactions with cross-functional teams...SeniorRegulatory
- Zai Lab is seeking an Associate Director, Regulatory Affairs in South San Francisco, CA to lead regulatory strategy and execution for clinical programs across regions. This role collaborates with senior leadership to prepare submissions and manage health authority interactions...SeniorRegulatory
- ...development programs, with collaboration across research and regulatory functions. The successful candidate will manage multiple programs... ..., and ensure high-quality regulatory documents for CTD, IND, NDA/BLA/MAA submissions, while contributing to templates and adopting...SeniorRegulatory
$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San Francisco, Californiatime... ...supply chain, CMC, quality, regulatory, program & portfolio management.This... ...experiences of leading a CMC team through IND and NDA/MAA preferred. + Must possess good scientific...SeniorRegulatory- ...in South San Francisco, seeks a Senior Director, Small Molecule Drug Discovery... ...in Inflammation Discovery to lead early inflammation research from target ID through IND/FIH. You will shape portfolio... ...advancing clinical strategy and regulatory support. #J-18808-Ljbffr...SeniorRegulatory
- ...is seeking an Associate Director, Regulatory Affairs in San Francisco. This... ...drive global regulatory submissions (IND/CTA) and help shape the development... ...stock options. Reporting to the Senior Director, Regulatory Affairs, you’ll lead regulatory strategy, coordinate cross...Regulatory
- ...South San Francisco seeks an Associate Director in Toxicology to lead nonclinical safety strategies for multiple programs. You will... ...and influencing program decisions that ensure patient safety and regulatory success. The ideal candidate holds a PhD with 10+ years of...SeniorRegulatory
- Scorpion Therapeutics in South San Francisco is seeking a Senior Clinical Data Manager Lead to guide data collection, standardization, and quality... ...ensuring compliance with ICH/FDA, CDISC standards, and regulatory expectations. This role requires strategic problem-solving...SeniorRegulatory
- Rigel Pharmaceuticals Inc. is seeking a senior leader to integrate translational medicine, clinical pharmacology... ...preclinical and clinical insights to drive IND-enabling activities through development and regulatory submissions, with a focus on high-impact programs and...SeniorRegulatory
- ...Associate Director of CMC Program Management to lead end-to-end CMC strategies, cross-... ...governance with CMOs/CDMOs, ensuring timely NDA filings and launch readiness. The role... ...ability to navigate complex programs across regulatory and commercial #J-18808-Ljbffr ORIC...SeniorRegulatory
$114.7k - $212.9k
...Roche group, seeks a Principal Quality Compliance Specialist to lead site quality initiatives and serve as the digital compliance... ...with Operations, MSAT, QA, QC, and Engineering to uphold global regulatory standards. Relocation assistance is available. The role offers...SeniorRegulatoryRelocation package$360k - $420k
Senior Vice President,Preclinical Toxicology NurixTherapeutics... ...external partners, and regulatory authorities. The SVP... ...three dimensions: leading aninternal team and... ...and genetic toxicology IND-enabling studies (GLP and... ..., including IND, CTA, NDA, BLA, andMAAsubmissions...SeniorRegulatory- Nurix Therapeutics is seeking a Sr. Director, Head of Regulatory & Medical Writing to lead the medical writing group and shape the strategy for key regulatory... ...directing regulatory writing for major submissions (NDA, BLA, MAA), a deep understanding of GCP/ICH and FDA #J-1...SeniorRegulatoryContract work
- ...facility in Holly Springs, North Carolina. We seek a Principal Quality Compliance Specialist with extensive GxP experience to lead digital regulatory initiatives and risk-based QMS embedding across site operations. You will champion continuous improvement, oversee...SeniorRegulatory
$186k - $235k
Structure Therapeutics in South San Francisco seeks an Associate Director of Medical Writing. The role includes leading the development of regulatory documents and performing quality control reviews to ensure compliance. The ideal candidate will have over 5 years of experience...SeniorRegulatory$247k
...excited to add a Project Team Leader (PTL) to lead projects and portfolio related activities... ....Leading Project Teams from pre-IND to Phase III Go to deliver first/ best-in... ...Research, Development, Commercial, Finance, Regulatory and Manufacturing.Utilize his/her deep understanding...SeniorRegulatoryFull timeLocal areaRelocation package$299k - $349k
...global biopharmaceutical company in California is seeking a Senior Medical Director to lead late-stage clinical development programs in Oncology.... ...and collaboration with cross-functional teams to ensure regulatory compliance. The pay range is between $299K and $349K per...SeniorRegulatory- Genentech is seeking a Senior Statistician in Biostatistics to lead statistical input for trial design, develop analysis plans, and oversee complex analyses... ...with cross-functional teams to ensure rigorous regulatory submissions and robust interpretation of study results...SeniorRegulatory
- ...translate nonclinical data into human PK and dose predictions. The role requires a PhD in pharmacokinetics or related field, 2+ years of DMPK project leadership, and strong communication skills to inform senior stakeholders and regulatory discussions. #J-18808-Ljbffr RocheSeniorRegulatory
$224k - $299k
...seeking a Director (or Senior Director) of Translational... ...patients' lives by leading translational medicine... ...medicine function, from IND/CTA through clinical proof-... ...strategy, GCP adherence, and regulatory-authority interactions,... ...proof-of-concept to NDA/BLA submissionAI/ML...SeniorRegulatoryWork at officeHome officeFlexible hours3 days per week- ...Onsite four days a week at South San Francisco or San Diego offices. You will lead monitoring oversight plans, assess reports, and guide clinical ops teams to mitigate risks and ensure regulatory compliance. Strong analytical and communication skills are essential. #J-18...SeniorRegulatory
$254.13k - $289.39k
...responsible for providing regulatory writing expertise and... ...brochures and annual updates IND submissions and annual... ...Information Amendments NDA, BLA, MAA, (e)CTD... ...required. Work effectively and lead in cross-functional... ...study protocol design, CTA/IND submissions, investigator...SeniorRegulatoryOdd jobFor contractorsFlexible hoursShift work- A biotech research company in South San Francisco seeks an Associate Director of Medical Writing to lead the development of high-quality clinical and regulatory documents. The ideal candidate must possess a Master's degree and over 8 years of experience in scientific writing...SeniorRegulatory
$131.4k - $206.8k
...applications. This individual will partner with various research and regulatory functions to prepare high-quality scientific and regulatory... ...filings for nonclinical modules in the context of CTD, IND, CTA, IMPD, NDA/BLA/MAA. Excellent scientific writing and editing skills...SeniorRegulatoryWork at office- ...Product Safety Team (PST) lead for late stage oncology... ...architects, safety PM, and other cross functional... ...PK and toxicology leads, regulatory and clinical development... ...safety components of pre-NDA and NDA/sNDA submissions... ...regulatory submissions (IND/BLA submissions) is...SeniorRegulatory
- ...an experienced Medical Writer to join the Nonclinical Pharmacology Documentation group. You will generate preclinical reports and regulatory submission modules, partnering with research and regulatory teams to ensure high-quality scientific and regulatory documents...SeniorRegulatory
- Kardigan seeks a Senior Director, CMC Regulatory to lead the development and execution of CMC regulatory strategies driving global submissions and... ...affairs, strong FDA/EMA/ICH knowledge, and experience with IND/IMPD and NDA/MAA submissions, preferably in small molecules. #J-1...SeniorRegulatory
$258k - $320k
...experienced team has secured partnerships with leading global biopharmaceutical companies,... ...Responsible for leading the global CMC regulatory strategy and execution for both small... ...molecules and biologics, including IND/ CTA , NDA/BLA/ MAA applications. Oversee the end...SeniorRegulatoryWork at officeWorldwideRelocation packageZai Lab (US) LLC
South San Francisco, CA12 days ago- Dispatch Bio seeks a Senior Associate, Regulatory Affairs to join a small, high-impact regulatory team reporting to the VP, Head of Regulatory Affairs... ...Regulatory Affairs in biotech/pharma, with experience in IND submissions and FDA/ICH guidelines, and thrives in a fast-...SeniorRegulatory
- Scorpion Therapeutics seeks a senior Quantitative Systems Pharmacology (QSP) leader to define modeling strategy across... ...partnerships, manage budget/planning, and ensure regulatory-grade deliverables for IND/NDA discussions. Oncology expertise and programming in MATLAB...SeniorRegulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory PM Lead for IND/CTA to NDA. Be the first to apply!
Related searches
- senior associate attorney South San Francisco, CA
- senior developer South San Francisco, CA
- senior aws cloud engineer South San Francisco, CA
- remote senior salesforce administrator South San Francisco, CA
- senior marketing operations manager South San Francisco, CA
- senior manager tax South San Francisco, CA
- senior property accountant South San Francisco, CA
- sr. manager regulatory compliance South San Francisco, CA
- senior tax South San Francisco, CA
- senior regulatory manager South San Francisco, CA