Regulatory Strategy Lead: FDA & IVDR Submissions
Natera
Natera is seeking a Regulatory Advisor focused on FDA Pharma and IVDR to drive regulatory strategy across programs and geographies. You will coordinate submissions, mentor staff, and partner with cross-functional teams to ensure compliant product registrations and labeling.This role requires deep knowledge of US FDA, EU IVDR, and IVD/LDT standards and a proactive, data-driven approach.J-18808-Ljbffr Natera
$182.1k - $338.3k
...all.The Principal Content & Evidence Submission Strategy Lead is focused on developing the medical communications... ...silos, interpret external legal and regulatory landscapes, and lead cross-functional... ...GCP, OIG guidelines, US Regulatory/FDA requirements, and drug access....RegulatoryFull timeLocal area- ...Solutions in Menlo Park, CA seeks a Director of IT to lead our client’s technology strategy and secure, scalable operations. You will balance hands... ...stakeholders, drives a robust AWS infrastructure, ensures regulatory compliance, and builds resilient systems. #J-18808-...Regulatory
- ...Biostatistician in South San Francisco, CA to shape the statistical strategy for late-stage clinical programs from first-in-human through pivotal Phase 2/3 trials and NDA/MAA submissions. You will lead study deliverables, mentor staff, and interact with regulators and cross...Suggested
$211k - $264k
...patients.The Opportunity:The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving... ...functional development & regulatory submission activities for registrational... ...effective & consistent regulatory strategies to enable successful filing of approval...RegulatoryFull timeWork experience placementLocal areaWorldwide- Vaxcyte is seeking a senior regulatory affairs professional to lead global CMC strategies for multi-product investigational vaccines. You will manage CMC submissions, interact with Health Authorities, and guide cross-functional teams to meet global regulatory requirements...RegulatoryRemote job
- ...experienced new member of our Regulatory team who will own the strategy and operations for our... ...’s programs and play a leading role in building out the... ...and other CMC regulatory submissions. Act as Retro’s regulatory... ...-authority meetings with FDA and other health...Regulatory
$302.01k - $390.83k
...California.Executive Director, PDM Product Strategy LeaderKEY RESPONSIBILITIESReporting to... ...(PDM) organization, this role leads strategic cross-functional teams responsible... ...formulation development activities along with regulatory, supply chain, and quality strategies...RegulatoryFull timePart timeFor contractorsLocal areaWorldwide- Genentech is looking for a PDQ Principal Quality Lead in South San Francisco, CA. This role requires a seasoned... ...professional to develop and execute quality strategies, manage audits, and ensure compliance with regulatory standards. Applicants should have at least 10 years...Regulatory
- ...leader to foster a vibrant youth creator ecosystem while upholding safety and quality principles. You will shape strategies to navigate a evolving regulatory landscape and partner across the monetization ecosystem to set new safety and quality standards. You will...Regulatory
$210.38k - $272.25k
...Gilead Sciences seeks a Global Manufacturing ERP Strategy Lead to establish and govern enterprise resource planning processes across clinical... ..., IT, finance, supply chain, and quality Strong understanding of compliance, audit readiness, and regulatory requirements...Regulatory$324.62k - $420.09k
...increasingly informing regulatory decisions across... ...Director, Regulatory RWE Strategy and Innovation is a scientific... ...programs, studies, submissions, and relationships... ...approaches deliberately and lead rather than react.The... ..., participate in FDA Type B/C meetings, EMA...RegulatoryFull timeFor contractorsLocal areaImmediate startShift work$298k - $350.6k
...Lead Medical Safety Physician Redwood City, California, United... ...and drive the medical safety strategy across the portfolio... ...cross-functional decisions Regulatory & Governance Oversee medical... ...PADERs, and regulatory safety submissions Support health authority interactions...RegulatoryFull time- Structure Therapeutics Inc. is seeking an Associate Director of Medical Writing to lead regulatory and clinical document development, ensure quality and compliance, and coordinate cross-functional inputs across Clinical Sciences, Regulatory Affairs, Biostatistics, and more...Regulatory
- Hinge Bio seeks an experienced Vice President of Regulatory Affairs to lead global regulatory strategy and execution for biologics, guiding programs from preclinical stages through IND submission and early clinical development. This senior leader partners with Clinical...Regulatory
- ...Revolution Medicines seeks a Director of Regulatory Affairs to lead global regulatory filings for late-... ...end-to-end NDA/MAA preparation and submission, coordinating cross-functional teams... ...regulatory affairs experience including strategy role Proven track record executing...Regulatory
- ...Attorney / Counsel - Junior / Senior / Lead Menlo Park, California, United States... ...agency with a specialized vertical in Legal, Regulatory Compliance, and Corporate Governance. We... ...record of impactful cases, regulatory submissions, process improvements, policy frameworks...RegulatoryContract work
- ...stealth stage biopharmaceutical client. You will lead CMC development from PCC nomination through IND submission, coordinating timelines, budgets, and cross‑... ...and a proven ability to drive CDMO partnerships, regulatory compliance, and manufacturing readiness for clinical...Regulatory
$145k - $165k
...compliance California FDB and US FDA QSR requirements. This... ...Review and interpret quality/regulatory compliance requirements and ensure... ...and quality plans and strategies in concert with affected functional... ..., recent involvement in 510k Submissions, IDE Submission, and/or CE...RegulatoryContract work- ...in Brisbane, CA, seeks a Director, Regulatory Affairs (Strategy, I&I) to lead global regulatory strategy for immunology... ...to enable timely regulatory submissions and lifecycle management in a fast-... ...quality submissions and interact with FDA/EMA, driving strategy aligned with...Regulatory
- ...Therapeutics seeks a senior scientist to lead and mentor the CMC Analytical... ...brain barrier. You will drive analytical strategy across oligonucleotide and small-molecule... ...methods, and coordinate CROs/CDMOs and regulatory submissions, ensuring rigorous GxP compliance and...Regulatory
- ...San Francisco, CA, is seeking a Director of PKDM-BA for Small Molecule Portfolio Strategy & Leadership to guide discovery through clinical development and regulatory submission. You will lead cross-functional teams, shape portfolio strategy, and drive scientific and...Regulatory
- Karius seeks a Staff Biostatistician to lead statistical strategy across complex studies. You will mentor analysts, shape endpoints, handle regulatory submissions, and apply advanced methods to clinical and genomic data to inform diagnostics and patient care. The role...RegulatoryRemote work
- ...Lead Cytopathologist It started with a simple idea: what if surgery could... ...for dataset curation, annotation strategy, and algorithm evaluation, ensuring... ...dataset curation Experience with regulatory frameworks for medical data (FDA, CE, HIPAA) Up to 20% travel Additional...RegulatoryWork at officeLocal areaWorldwideFlexible hours
$213k - $396k
...development (Phase II - III) clinical strategies and plans that deliver... ...improvement to patients.The Lead Medical Director leads or... ...role with other CST members, regulatory and other internal partners/stakeholders... ...in the completion and submission of regulatory filings and...RegulatoryFull timeLocal areaRelocation package- Zai Lab Limited seeks a senior CMC regulatory leader to drive global regulatory strategy for both small molecules and biologics from its South San Francisco office. You will oversee IND/CTA and NDA/BLA submissions, coordinate with health authorities, and guide cross-functional...RegulatoryWork at office
- Kardigan seeks a Senior Director, CMC Regulatory to lead the development and execution of CMC regulatory strategies driving global submissions and interactions with health authorities.... ...10+ years in regulatory affairs, strong FDA/EMA/ICH knowledge, and experience with IND...Regulatory
$261.38k - $338.25k
...Sciences seeks a Senior Director to lead real-world evidence strategy for inflammation therapeutics... ...cross-functionally with clinical and regulatory stakeholders, and ensures robust epidemiologic... ...product development and regulatory submissions Lead team of observational...Regulatory$203.8k - $326.1k
...you.Job DescriptionVisa is seeking a Director, Product Strategy & Operations to help lead the growth and execution of Agentic Commerce within the... ...objectives.Evaluate market trends, competitive dynamics, regulatory movement, and tech innovation to inform GTM narrative and...RegulatoryFull timeWork experience placementWork at officeLocal areaFlexible hoursShift work$215k - $240k
...on our journey towards becoming a leading rare disease company.Ascendis Pharma... ...looking to hire an experienced Director, Regulatory Affairs Clinical Strategy to join our team. This is an... ...organized and scientifically valid submissions. Provides expertise in translating...RegulatoryFull timeTemporary workFlexible hours$324.62k - $420.09k
...seeks an Executive Director to lead enterprise-wide real-world evidence strategy and innovation for regulatory decision-making. This role... ...use of RWE in health authority submissions. Responsibilities... ...engagement Strong knowledge of FDA and EMA regulatory pathways and...Regulatory
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