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
$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- Denali Therapeutics Inc is seeking an experienced Regulatory Project Manager to drive the regulatory strategy and timelines across a portfolio of neurodegenerative disease programs. You will partner with Regulatory Affairs, Medical Writing, Operations, and development...SeniorRegulatory
- Erasca, Inc. is seeking a Senior Manager or Associate Director of CMC Regulatory Affairs to lead regulatory activities for IND/CTA development, with future MAA/NDA/BLA planning. This high-profile role requires an independent, self-directed regulatory professional with oncology...Regulatory
$175k - $205k
...Manager/Assoc Director, CMC Regulatory Affairs San Diego, CA,... ...Affairs, the Senior Manager or Associate Director... ...Regulatory Affairs will lead and participate in... ...activities associated with IND/CTA development and maintenance... ...for future MAA/NDA/BLA(s). This role requires...SeniorRegulatoryTemporary workCasual workLocal areaRemote workWorldwideFlexible hours- The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) leads initiatives to develop and manage regulatory strategies for CMC submissions, including INDs/CTAs and amendments. This role builds relationships across Regulatory Affairs, Operations...SeniorRegulatory
- Maze Therapeutics seeks a Senior Manager, Trial Master File (TMF) to lead TMF strategy and governance across the clinical portfolio. You will drive the... ...8+ years in TMF or clinical operations, with strong regulatory knowledge and leadership capabilities in a biotech setting...SeniorRegulatory
- ...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
$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$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- CareDx, Inc. is seeking a Sr. Staff Biostatistician to lead statistical strategy for biomarker discovery and to contribute to product... .... The role involves clinical study design, advanced analyses, regulatory support, and mentoring of junior staff. The position requires...SeniorRegulatoryRemote job
- ...document completeness, and drive governance through SOPs, metrics, and CAPA processes, partnering with Clinical Operations, Quality, Regulatory Affairs, and IT to support scalable, compliant trials. The role emphasizes inspection readiness, regulatory alignment, 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
- Rigel Pharmaceuticals, Inc. is seeking a Senior Manager, Medical Information to lead development, review, and lifecycle management of scientific response... .... This role collaborates with Medical Affairs, Regulatory, Legal, and other functions and requires strategic thinking...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$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- Veratherapeuticsinc seeks a Senior Manager, Regulatory CMC to manage regulatory submissions and activities within a dynamic team. This role requires... ...knowledge, organizational skills, and the ability to lead cross-functional projects. Candidates should have at least...SeniorRegulatory
- 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
$155.2k - $288.2k
...and transformingsociety.About this Marketing RoleThis Senior Manager, Omnichannel Engagement Lead role is integral to successfully delivering the... ...channelsKnowledge of the healthcare ecosystem including policy, the regulatory environment and each customer type (e.g. HCPs,...SeniorRegulatoryFull timeWork experience placementWork at officeLocal areaRelocation packageFlexible hours3 days per week- ...Therapeutics, based in South San Francisco, seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for our... .... The candidate will oversee high‑quality CTA/IND and BLA/MAA filings for biologics, manage the...SeniorRegulatory
- Neurona Therapeutics in South San Francisco, CA, seeks a Senior Manager / Associate Director, Regulatory Affairs to guide regulatory strategy across clinical and CMC for ATMPs. You will lead submissions (IND/CTA/BLA/MAA), interact with health authorities, and shape regulatory...Regulatory
$245k - $285k
...candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes... ..., the position assists corporate senior management in understanding CMC... ...commitments are met with respect to INDs, BLAs, CTA, MAAs, etc. Prep and author updates...SeniorRegulatoryContract work$244k - $305k
...harboring mutations in the RAS signaling pathway. The Opportunity: The Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory strategy for assigned molecule(s) from IND-enabling activities through registration and lifecycle management....SeniorRegulatoryFull timeLocal area- ...Inc. in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs. You... ...role requires strong scientific writing, experience with INDs/NDA/MAA filings, and deep knowledge of eCTD structures. #J-18...Regulatory
- A leading staffing solutions firm is seeking a Sr. Veeva Business Analyst in South San Francisco, CA. The ideal candidate will have over 5 years of experience in the pharmaceutical or medical devices industry, along with at least 4 years of Veeva CRM administration expertise...Senior
$220k - $270k
...hiring a Director, CMC Regulatory Affairs, to join our Technical... ...is responsible for leading CMC regulatory... ...packages in support of INDs, CTAs and amendments to... ...sections of M2 and M3 of IND,NDA, and IMPD. Fluency with... ...$250,000-$300,000 for Senior Director, level...SeniorRegulatoryH1bCurrently hiring- ...for employment. Position: Senior Manager / Associate Director, Regulatory Affairs Location: South... ...regulatory submissions, including INDs, CTAs, meeting requests,... ...keep programs on track Lead or support health... ...regulatory filings (e.g., IND, CTA, BLA, MAA) and leading or...SeniorRegulatoryWork at officeShift work
- ...Manager for mechanical systems, thermal solutions and manufacturing. Lead hardware programs from concept to mass production, coordinating... ...are essential. The role requires 5+ years in technical PM, NPI, or related fields, with Mandarin and English fluency. #J-1...Senior
$165k - $195k
...leadership and support to global regulatory activities to achieve Alumis' strategic... ...of regulatory approvals. Lead preparation, review and submission of INDs/CTAs, amendments, review and approval... ...regulatory filing(s) such as IND/CTA. Working knowledge of FDA regulations...SeniorRegulatoryHourly payContract workWorldwide- Job Title: Senior Scientist, Drug Product Skills: NDA, Drug Product, Analytical Chemistry About the Pharmaceutical... ...This role offers the chance to lead analytical development and... ...reports, data packages, and regulatory filings such as INDs, NDAs, and annual reports....SeniorRegulatoryContract work
- ...cross-functional stakeholders across Coinbase entities to deliver globally coordinated, locally relevant risk outcomes, and develop governance materials for regulatory audiences. A focus on AML/CFT, sanctions, and TM/CRS coverage is essential. #J-18808-Ljbffr CoinbaseSeniorRegulatory
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