Director, Regulatory Affairs - Clinical (FDA CVM)
$155k - $205kLoyal
Loyal is seeking a Director of Regulatory Affairs, Clinical responsible for developing regulatory strategies for FDA approval of longevity drugs for dogs. The ideal candidate will have 10+ years of experience, particularly in animal health regulatory affairs, and will serve as a subject matter expert, leading submissions and interfacing with FDA. This role includes managing direct reports and collaborating across teams in a dynamic startup environment. Competitive salary range: $155,000 - $205,000 with extensive benefits including unlimited vacation and equity options. #J-18808-Ljbffr Loyal
$155k - $205k
Loyal is a clinical-stage veterinary medicine company... ...toward our first regulatory approvals, with additional... ...our path of earning FDA approval for the... ...seeking an experienced Director Regulatory Affairs, Clinical to serve as... ...Veterinary Medicine (CVM) regulatory strategy...SuggestedHome officeWeekend work$95.45k - $143.18k
DescriptionThe Director of Regulatory & Administrative Affairs for the Mount Sinai Institute for Transformative Clinical Trials provides strategic leadership and operational oversight for... ...will have demonstrated experience with FDA and Health Canada submissions, including...SuggestedTraineeshipWork at officeLocal area- ...MarketJob Title / Position:Director/Senior Director Regulatory AffairsDepartment:... ...Senior Director of Regulatory Affairs will report to the Vice President... ...with nonclinical, CMC and clinical development plans and... ...and lead negotiations with FDA, EMA, MHRA and other health...SuggestedRemote work
- Meditrial seeks a strategic leader to head Regulatory & Clinical Affairs, reporting to the Chief Medical Officer. You will develop global regulatory... ..., leveraging a deep regulatory network and experience with FDA and Notified Bodies. The role collaborates across functions...Suggested
- ...Meditrial leadership team, providing strategic direction to the Regulatory & Clinical Affairs teams, and is responsible for the development and execution... ...medical and biotech community, KOLs, Notified Bodies and FDA. The profile will work in close contact with and report to...SuggestedWork at officeWorldwide
- A leading clinical data standards firm is seeking a highly experienced Data Standards Manager III to ensure clinical data standards are applied across studies. The ideal candidate will manage eCRF design, SDTM mapping, and validation processes, while guiding cross-functional...Remote job
- ...seeking a highly experienced Data Standards Manager III to join our Clinical Data Reporting & Standards team. This role plays a critical... ...applied across studies, from data collection through regulatory submission. The ideal candidate is a subject matter expert in...Remote work
$117k - $208k
...innovation. They are responsible for identifying high-value clinical and operational friction points and vetting solutions... ...elsewhere.Risk Assessment & Mitigation:Evaluate regulatory and compliance hurdles (HIPAA, FDA approvals, or Joint Commission standards).Perform a "...TraineeshipLocal area- ...Specialty Health Incorporated (ASH) seeks an Associate Manager-Clinical Scope & Coding Compliance to join our Clinical Quality... ...will work with cross-functional teams, review legislation and regulatory guidance, and help develop QI studies and education across CQI...
- ...Sciences A well-established life sciences consultancy is seeking an experienced Director of Regulatory Affairs to provide strategic and operational leadership across regulatory and clinical research activities. This role partners closely with executive leadership and plays...Full timeRemote work
$228.25k - $280.72k
...the delivery of high-potential drug candidates to the clinic. We are seeking a Director of Regulatory Affairs who will play a critical role in supporting global... ...Affairs, experience with major Health Authority (US FDA, Health Canada, UK MHRA and EMA) is mandatory. Oncology...Odd jobWork at officeLocal areaImmediate startRemote workWork from home- ...A clinical-stage biotech is seeking a Director, Regulatory Affairs to support regulatory strategy and execution across its development pipeline. This is a hands-on,... ...regulatory milestones while ensuring alignment with FDA and global regulatory requirements. This is an...
$193.63k - $254.14k
...multiple myeloma. Legend Biotech is seeking a Director, Regulatory Affairs as part of the Regulatory Affairs team... ...filings as required. Interface with the FDA and other health authorities to seek feedback and alignment on pre‑clinical and clinical development strategies....Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours$120k - $150k
A renowned healthcare organization in New York seeks an Assistant Director of Finance to manage clinical trial budgets and ensure compliance with regulations. The ideal candidate will hold a Master's degree and possess over five years of experience in budget development...Local area- Director, Regulatory Affairs - Permanent - Remote Proclinical is seeking a (Senior) Director, Regulatory... ...fibrosis programs. This role will lead FDA engagement and regulatory data positioning... ...focus on leveraging foreign clinical data to support U.S. regulatory pathways...Permanent employmentRemote work
$71.4k - $73k
...time of posting. Position Summary The Regulatory Manager provides operational and strategic... ...quality assurance activities across assigned clinical research portfolios. This role... ...institutional policies, HIPAA, ICH-GCP, FDA regulations (21 CFR), OHRP guidance, sponsor...Temporary workWork at officeLocal area- Recursion Pharmaceuticals is seeking a Director of Regulatory Affairs to shape global regulatory strategy and steer execution across jurisdictions, including US, EU, and UK, for clinical and late-stage programs. You will lead global submissions, manage RA risks, collaborate...Remote job
- Lexitas Pharma Services, Inc. seeks a Fractional Director of Regulatory Affairs to provide strategic leadership and hands-on execution across the FDA centers, with deep ophthalmic product expertise. This role partners with development teams to navigate regulatory pathways...
$152.24k - $161.2k
...Report recently placed 12 of its clinical specialties among the top 10... ...to join our team as a Regulatory Standard Manager. In this role... ...with the Office of Regulatory Affairs leadership and staff to ensure... ...meetings Works with Senior Directors Regulatory to assure that data...Work at office- Montefiore New Rochelle is looking for a Program Manager Clinical Research to oversee compliance and quality assurance within the Cancer Clinical Trials Office. This role involves managing clinical research monitoring activities and providing constant feedback on compliance...Work at office
- ...company focused on psychiatry and psychedelics. We seek a Director of Late-Stage Clinical Development to lead end‑to‑end strategy for Expanded... ...setting, with collaboration across Clinical Development, Regulatory, HEOR, and Commercial teams. #J-18808-Ljbffr Definium TherapeuticsRemote job
- Pharmaron is seeking a Director of Biostatistics to lead the Biometrics organization, guiding statistics strategy across clinical development from Phase I to IV. You will partner with cross-functional teams and clients to deliver scientifically rigorous statistical solutions...Remote job
- Tendo is seeking a senior individual contributor with director-level strategic scope at the intersection of clinical medicine, healthcare quality benchmarking, and applied data science/AI. You will translate clinical nuances into data science problems and build production...Remote job
$170k - $352.5k
...multidisciplinary team on high-risk cases. Candidates must possess an MD or DO degree and have at least five years of experience in clinical care. The position offers a competitive salary range of $170,000 to $352,500, depending on qualifications and experience. #J-18808...- ..., Inc. in the United States seeks an Associate Director, Supply Chain Product Planning to lead integrated clinical and commercial forecasting, and to align master... ...allocations while ensuring compliance with cGMP and regulatory requirements. Travel 10-20% is expected. #J-18...Remote work
- Mount Sinai Health System seeks a Director of Clinical Pharmacy Services to provide strategic and operational leadership for enterprise programs... ..., with emphasis on medication-use optimization, analytics, regulatory readiness, workforce development, and research. #J-18808-...
$130k - $164.6k
...Site: Job Description Summary The Senior Manager, Global Clinical Regulatory Lead, is responsible for providing strategic and operational... ...products. This position collaborates with others in the Regulatory Affairs Strategy team, Regulatory Subteams, and potential cross-...Odd jobContract workTemporary workLocal area- ...exclusive features. Description Ready for a New Challenge? Keep Your Clinical Skills Sharp—From Home! Are you a Registered Nurse (RN)... ...of quality, integrity, and compliance with client agreements, regulatory guidelines, and federal/state mandates. Why This Role Rocks 10...Local areaRemote workWork from homeMonday to FridayNight shiftRotating shift
- Jazz Pharmaceuticals is a global biopharma company seeking a Director of Clinical Quality Assurance to ensure clinical research activities meet ICH GCP, regulations and Jazz standards. You will lead the CQA team, drive risk-based quality initiatives, and champion quality...
$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: NYC, NYGaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory direction for first-in-class cell therapies...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week
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