Regulatory Affairs Director — Post-Approval Strategy
Jobleads-US
Orca Bio, a leading biotechnology company, seeks a Senior Director of Regulatory Affairs to lead regulatory strategy and execution. You will work with the CMO and executive leadership to shape regulatory pathways for post-approval operations and future development programs.
You will mentor a growing team and collaborate across Clinical, CMC, Quality, and Commercial groups to ensure timely submissions, lifecycle management, and readiness for global expansion.
#J-18808-Ljbffr Jobleads-USVacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Director — Post-Approval Strategy in Menlo Park, CA vacancy
- ImmunEdge is seeking an experienced Regulatory Affairs leader to develop and execute global regulatory strategies across its portfolio of innovative therapeutics. You will partner with Clinical Development, CMC, Nonclinical, Quality, and leadership to translate regulatory...Suggested
$324.62k - $420.09k
...increasingly informing regulatory decisions across... ...EpiRWE), the Executive Director, Regulatory RWE Strategy and Innovation is a... ..., Global Regulatory Affairs, Biostatistics,... ...expansion, address post-marketing requirements... ...contributed to a submission, approval, label expansion, or...SuggestedFull timeFor contractorsLocal areaImmediate startShift workGILEAD Sciences
San Mateo, CA2 days ago$215k - $240k
...dynamic workplace for employees to grow and develop their skills.Ascendis Pharma is looking to hire an experienced Director, Regulatory Affairs Clinical Strategy to join our team. This is an exciting opportunity to join a rapidly growing, innovative company!Position...SuggestedFull timeTemporary workFlexible hoursascendis pharma
Palo Alto, CA2 days ago- Ascendis Pharma in Palo Alto, CA seeks a highly experienced Director, Regulatory Affairs Clinical Strategy to lead global regulatory strategies across clinical, non-clinical, and CMC disciplines. This role requires coordinating with international teams, mentoring staff...Suggested
- GRAIL is seeking a Director/Associate Director, International Regulatory Affairs to steer global regulatory strategy and align portfolio decisions with health authorities. The role... ...regulatory submissions, product approvals, and lifecycle management across geographies...Suggested
- Ascendis Pharma is seeking an experienced Director, Regulatory Affairs Clinical Strategy in Palo Alto, CA to lead global regulatory plans across clinical, non-clinical, and CMC disciplines. You will guide submissions, mentor team members, and partner with cross-functional...
$120.28k - $160.15k
Director of Operations, Administration, and Strategy - Graduate School of Education, Stanford University - Brain Development... ...growing program that has been approved as a universal screener across... ...of industry standards and regulatory requirements. Ability to multi‑...Contract workWork at office$120.28k - $160.15k
Director of Operations, Administration, and Strategy Stanford, CA, United States (Hybrid) Job Description The Brain... ...growing program, having been recently approved as a universal screener across... ...in industry standards and/or regulatory requirements. Ability to multi‑...Hourly payFull timeContract workFixed term contractCasual workWork at officeFlexible hours- Corcept Therapeutics Incorporated in Redwood City, CA, is seeking an Associate Director of Regulatory Affairs to lead regulatory strategy and submissions for domestic and international programs. You will partner with cross-functional teams, guide submissions, and ensure...
$157.59k - $203.94k
...possible, together.Job DescriptionAs a Senior Manager, Supplier Strategy and Management, Devices at Gilead you will own the business... ...manage strategic suppliers of direct materials in alignment with approved Portfolio Management Team (CMT) strategies.Support make vs. buy...Full timeFor contractorsLocal areaGILEAD Sciences
San Mateo, CA6 days ago- ...and C3 Generative AI, a suite of domain-specific generative AI offerings for the enterprise. Learn more at: C3 AIC3 AI is seeking a Strategy Manager to execute and accelerate C3 AI's go-to-market strategy. As part of the Strategy team, you will drive critical go-to-...
C3 IoT
Redwood City, CA3 days ago - ...run on the operating systems built behind them. As Senior Director, Revenue Strategy, Planning and AI, you'll own that system at Intapp: the annual... ...or for any payment during the job application process. We post all legitimate job openings on the Intapp Career Site at ....Full timeLocal areaWorldwideFlexible hours
Intapp
Palo Alto, CA6 days ago $183k - $194k
...executes multi-product global regulatory CMC strategies for investigational... ...Functions:Represent Regulatory Affairs in various internal cross-functional... ...and filings.Review and approve change controls related to... ....Reports to: Executive Director, Regulatory CMC Location: US...RelocationRelocation packageVaxcyte
San Carlos, CA4 days ago$213k - $319k
...’re empowered to do your best work. Job Summary The Director, Channel Strategy owns the multi-year analytical and strategic plan for the... ...based on our compensation structure in place at the time of posting and may be updated periodically based on business needs....Full timeWork at officeEquinix, Inc.
Redwood City, CA2 days ago- ...enhance sales pipelines and account intelligence. Own Seamless Post-Sales Delivery: Partner closely with customers and Applied AI... ...Conduct regular business reviews to assess progress and align strategies with customer goals. Point of contact Account Management to...Local area
Databook
Palo Alto, CA1 day ago - ...Role Summary The Head of Regulatory is responsible for ensuring Hippocratic... ...report to the SVP of Medical Affairs, and work closely with the... ...Regulatory Strategy and Oversight Define and maintain... ...evidence-based, and aligned with approved labeling and non-promotional...
Hippocratic AI Inc.
Menlo Park, CA2 days ago $171.7k - $202.64k
...2,644Director of Student-Athlete Alumni Strategy & Engagement Stanford’s Department of Athletics... ...you to apply!Position SummaryThe Director of Student-Athlete Alumni Strategy & Engagement... ...-building.[REMOVE STATEMENT BEFORE POSTING - KEEP LANGUAGE BELOW, IF APPLICABLE....Full timeInternshipNight shiftStanford University
Palo Alto, CA2 days ago$214.94k - $260.29k
...all people.Position OverviewThe Precourt Institute for Energy seeks exceptional candidates for the role of Executive Director, Partnerships & Strategy. Reporting directly to and working closely with the Precourt Institute Director, the Executive Director will spearhead...Part timeWork at officeWork visa3 days per weekStanford University
Palo Alto, CA4 days ago- ...Customer Officer (CCO) organization, the Strategy & Program Management team owns the cross... ...pay for this role at the time of this posting. An employee’s position within the salary... ...with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v...Hourly payFull timeContract workSummer workInternshipLocal areaShift work
$250k - $300k
Menlo Park, CARegulatory Affairs - Regulatory Affairs /Regular,... ...Summary: The Senior Director, Head of Regulatory Affairs... ...for regulatory strategy which should be agreed... ...executive leadership approval. Following Orca Bio's... ...heavily weighted toward post-approval regulatory...Full timeLocal areaImmediate startRemote workOrca Bio
Menlo Park, CA5 days ago- ...everyone makes play happen. The Corporate Strategy team drives EA’s long-term growth and... ...executives, the CEO, and Board of Directors. Help promote EA's studio & franchise... ...in these locations at the time of this posting. If you reside in a different location,...Full timeLocal areaImmediate startWorldwideShift work
Electronic Arts
Redwood City, CA2 days ago $166.05k - $265.7k
## Director, HPS Solutions Finance StrategyPalo Alto, California, United States of AmericaFind out... ...you match with this jobJob Id3164754Job Posting Start Date2026-08-09WorkstyleFlexDirector, HPS Solutions Finance Strategy**Description -****Job Summary**We are seeking...Full timeTemporary workWork experience placementLocal areaRelocationFlexible hoursShift workHewlett Packard Co.
Palo Alto, CA2 days ago$211k - $264k
...patients.The Opportunity:The Director of Regulatory Affairs (Global Filing Lead) is accountable... ...& consistent regulatory strategies to enable successful filing of approval of New Drug Applications.Develop... ...The range displayed on each job posting is intended to be the base pay...Full timeWork experience placementLocal areaWorldwideRevolution Medicines
Redwood City, CA6 days ago$166.05k - $265.7k
Director, Commercial Channel Strategy**Description -****Job Summary**The Director of Channel Strategy is responsible for establishing the vision and leading... ...benefits information is accurate as of the date of this posting. The Company reserves the right to modify this...Full timeTemporary workLocal areaWorldwideRelocationFlexible hoursShift workHewlett Packard Co.
Palo Alto, CA2 days ago- Guardant Health is seeking a Senior Director, Tax to lead the company’s global tax function from its Palo Alto, CA location. You will own tax accounting, reporting, planning, transfer pricing, and SOX controls, partnering with Finance, Legal, and Operations to drive growth...
- ...together.Job DescriptionAs the Director of Trade Strategy within Gilead’s US Market... ...Markets, Government Affairs, Finance, Legal and executive... ...Contracts, Operations and Regulatory for new and discontinued... ...channel contracts within the approved strategy guidelines and...Full timeFor contractorsLocal area
GILEAD Sciences
San Mateo, CA7 days ago $400k
...program’s grantmaking is currently guided by the following core strategies: National Governing Institutions: This strategy strengthens... ..., and within the grantmaking portfolio held by the program director, the program has also recognized the central importance of rediscovering...Temporary workWork at officeLocal areaHewlett
Menlo Park, CA2 days ago- HP is seeking a Senior Strategy Director within the Personal Systems Strategy and Planning team in Palo Alto. The role leads AI strategy, competitive intelligence, and portfolio prioritization to accelerate growth and drive executive decision-making. Ideal candidate brings...
- Databook, a leading AI-guided selling platform, seeks a Senior GTM & Strategy lead to manage a portfolio of enterprise clients and partner... ...rates while expanding relationships. You will shepherd seamless post-sales delivery, coordinate with AI-enabled workflows, and lead...
$190.95k - $305.55k
Role Overview It is an exciting time to join the Strategy and Planning team within HP’s Personal Systems group, a $37B business within... ...actions that yield tangible outcomes. The Strategy and Planning Sr. Director will lead the high-impact strategy and competitive intelligence...Full timeWork experience placementLocal areaShift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Director — Post-Approval Strategy. Be the first to apply!
Related searches
- planning director Menlo Park, CA
- director of strategy Menlo Park, CA
- strategic planning manager Menlo Park, CA
- planning supervisor Menlo Park, CA
- strategic planning director Menlo Park, CA
- director strategy and innovation Menlo Park, CA
- planning manager Menlo Park, CA
- strategic director Menlo Park, CA
- regulatory engineer Menlo Park, CA
- clinical research regulatory Menlo Park, CA