Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Regulatory Affairs Director Post-Approval Strategy

A Medium Corporation

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
Vacancy posted 5 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

    ImmunEdge

    Redwood City, CA
    1 day ago
  •  ...Therapeutics, headquartered in Redwood City, California, seeks an Associate Director of Regulatory to lead interactions with domestic and international health authorities and to develop regulatory strategies for lifecycle management of products. The role collaborates across... 
    Suggested
    3 days per week

    Corcept Therapeutics

    Redwood City, CA
    3 days ago
  • $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... 
    Suggested
    Full time
    For contractors
    Local area
    Immediate start
    Shift work

    GILEAD Sciences

    Foster, CA
    5 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... 
    Suggested
    Full time
    Temporary work
    Flexible hours

    ascendis pharma

    Palo Alto, CA
    5 days ago
  •  ...Mainspring Energy is seeking an experienced legal or regulatory professional to lead the Company's strategy on environmental, energy, and regulatory matters. Reporting to the General Counsel, this individual will drive regulatory strategy, policy engagement, and compliance... 
    Suggested
    Remote work

    Mainspring Energy, Inc.

    Menlo Park, CA
    1 day 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... 

    Ascendis Pharma

    Palo Alto, CA
    1 day ago
  • $290k - $320k

     ...advancing novel therapeutic strategies that address this rare...  ...closely with Medical Affairs colleagues, Organized...  ...Exchange) before approval and PVP (Payer Value Proposal...  ...current legal and regulatory landscape pertinent to...  ...for the Executive Director, Payer Strategy and Engagement... 
    Contract work
    Work at office
    Local area
    Home office
    3 days per week

    Rezolute

    Redwood City, CA
    1 day ago
  • $183.3k - $265.8k

     ...Let's begin! Director, Product Regulatory Strategy - Property Insurance Data & AI (15677) Requisition ID 15677-Posted 10/23/2026- Newark - 7575 Gateway...  ...responses taken through approval; required because this role...  ..., Public and Regulatory Affairs team and aligning with... 
    Full time

    Moody

    Newark, CA
    1 day ago
  • $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‑task... 
    Hourly pay
    Full time
    Contract work
    Fixed term contract
    Casual work
    Work at office
    Flexible hours

    Stanfordlivetickets

    Palo Alto, CA
    4 days ago
  • 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... 

    Corcept Therapeutics Incorporated

    Redwood City, CA
    3 days ago
  •  ...clinical applications. The Assistant Director, Health AI Strategy & Operations will serve as a trusted...  ..., clinical, legal, or institutional approval. The portfolio may include AI-...  ...operational initiatives involving regulatory requirements, data governance, institutional... 

    Stanford University

    Palo Alto, CA
    1 day ago
  • $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 time
    For contractors
    Local area

    GILEAD Sciences

    Foster, CA
    4 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, CA
    1 day 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 time
    Local area
    Worldwide
    Flexible hours

    Intapp

    Palo Alto, CA
    4 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 time
    Work experience placement
    Local area
    Worldwide

    Revolution Medicines

    Redwood City, CA
    4 days ago
  • $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 time
    Local area
    Immediate start
    Remote work

    Orca Bio

    Menlo Park, CA
    3 days ago
  •  ...experienced legal or regulatory professional to lead the Company's strategy on environmental,...  ..., and Government Affairs to proactively...  ...and environmental approvals for manufacturing...  ...one U.S. state bar Director: 15+ / Senior Director...  ...meet all of our posted requirements? Studies... 
    Local area
    Remote work
    Flexible hours

    Mainspring Energy, Inc.

    Menlo Park, CA
    3 days 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, CA
    5 days ago
  • $250k - $275k

     ...seeking a highly motivated and experienced Senior Director of Regulatory Affairs to lead global regulatory strategy and operations across our development pipeline....  ...strategies to support timely development and approvals. Collaborate with internal stakeholders and external... 
    Work at office
    Remote work
    2 days per week
    3 days per week

    Amplitude Venture Capital

    Palo Alto, CA
    5 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, CA
    4 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 time
    Work at office

    Equinix

    Redwood City, CA
    1 hour ago
  • $170k - $190k

     ...dynamic and experienced Sr. Manager of Regulatory Affairs. The role is responsible for ensuring...  ...execution of the regional regulatory strategy in line with the global registration strategy...  ...(PoC), development, registration, and post-approval for projects within the company's... 
    Local area

    Bayside Solutions

    Palo Alto, CA
    4 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 time
    Internship
    Night shift

    Stanford University

    Palo Alto, CA
    5 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 time
    Local area
    Immediate start
    Worldwide
    Shift work

    Electronic Arts

    Redwood City, CA
    1 hour 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 time
    Temporary work
    Work experience placement
    Local area
    Relocation
    Flexible hours
    Shift work

    Hewlett Packard Co.

    Palo Alto, CA
    1 hour 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 time
    Temporary work
    Local area
    Worldwide
    Relocation
    Flexible hours
    Shift work

    Hewlett Packard Co.

    Palo Alto, CA
    1 hour ago
  •  ...Databook, a leading AI-guided selling platform, seeks a Senior GTM & Strategy lead to manage a portfolio of enterprise clients and partner...  ...while expanding relationships. You will shepherd seamless post-sales delivery, coordinate with AI-enabled workflows, and lead quarterly... 

    Databook

    Palo Alto, CA
    4 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 pay
    Full time
    Contract work
    Summer work
    Internship
    Local area
    Shift work

    Rivian

    Palo Alto, CA
    4 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... 

    HP

    Palo Alto, CA
    1 day ago
  • $182k - $260.4k

     ...Build the future of the AI Data Cloud. Join the Snowflake team. Snowflake’s Sales Strategy & Business Operations team is seeking a Sr Partner Strategy Manager, to help define and drive the company’s Partner go-to-market strategy and operating plan. Our goal is to expand... 
    Flexible hours

    Snowflake Computing

    Menlo Park, CA
    8 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Regulatory Affairs Director Post-Approval Strategy. Be the first to apply!