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
- ...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...SuggestedRemote work
- 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...SuggestedRemote job
$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...
$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$300k - $400k
...sized pharmaceutical company is seeking a Senior Vice President (SVP) of Regulatory Affairs in East Brunswick, New Jersey. This executive role will lead global regulatory strategy across CMC, Clinical, and Non-Clinical programs, and requires 15+ years of regulatory...- ...Kyverna Therapeutics seeks an Executive Director of Regulatory Affairs to lead global regulatory strategy for our autoimmune cell therapies from... ...labeling and health authority engagement. You will partner with Clinical, CMC, Commercial, Market Access, and Legal to ensure...Remote work
$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$189k - $246k
Department: 107000 Regulatory Location: San Diego, USA- Remote Position Summary The Director, Regulatory Affairs Strategy is responsible for developing... ...to support successful clinical development, registration,... ...authorities, including the FDA, EMA, and other regulatory...Temporary workLocal areaRemote workWeekend work$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- ...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...Full timeRemote work
- 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
$207.5k - $255.2k
...development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical trials and marketing applications.... ...and guidance. The Team You’ll Join As Director CMC Regulatory Affairs, you will be an essential member of the...Work at officeLocal areaRemote workWork from homeWorldwide- ...seeks a strategic and execution-focused Director of Regulatory Affairs to provide global regulatory... ...major strategic initiatives, including FDA and global health authority meetings,... ...Demonstrated experience supporting late-stage clinical development programs. Proven...
- 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...
- Recursion seeks a Director of Regulatory Affairs to shape global regulatory strategy and manage regulatory risks across programs. You will collaborate with clinical, medical, and commercial teams to align strategies with development plans, ensuring timely registrations...Remote job
- 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
$117k - $208k
Mount Sinai Medical Center in New York seeks a leader responsible for driving innovation by identifying clinical and operational barriers. The ideal candidate will have at least 5 years of experience in healthcare finance and a strong educational background, preferably...- CVS Health is seeking a Senior Manager of Clinical Innovation to drive complex strategic initiatives within the Clinical Solutions portfolio, guiding ideation through pilots to scalable programs. You will lead cross-functional teams and align priorities with clear business...
- Mount Sinai Health System seeks a Director of Clinical Pharmacy Services to provide strategic and operational leadership for enterprise clinical... ..., oversee P&T operations, and advance analytics, regulatory readiness, and workforce #J-18808-Ljbffr Mount Sinai Health...
- 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-...
- ...more about our team: -with-us Position Summary: The Director, Claims & Clinical Testing will lead e.l.f. Beauty’s global substantiation program... .... Partnering closely with Product Development (PD), R&D, Regulatory, Legal, and Product Innovation/Marketing, this leader...Full timeWork at officeWork from homeFlexible hours
$115.49k - $192.33k
The Icahn School of Medicine at Mount Sinai is seeking a Clinical Program Manager to oversee compliance and operational impact in designated nursing staff at the Staten Island clinic. The role involves managing educational programs, staff performance, and clinical outcomes...- Gofractional is seeking a Director of Regulatory Affairs (Fractional) to navigate FDA pathways across CDER, CBER and CDRH, and to coordinate agency interactions while shaping regulatory strategy. The ideal candidate will have extensive ophthalmology regulatory experience...Remote job
$65.6k - $109.2k
Strategic Account Manager, Clinical Solutions (Health) Drive Growth. Make an Impact. Transform Healthcare. Are you passionate about healthcare and ready to take your sales career to the next level?Do you thrive on building relationships, solving challenges, and helping...Temporary workWork at officeLocal areaImmediate startFlexible hoursNight shift- The Mount Sinai Health System in New York is seeking a Clinical Program Manager to ensure compliance with clinical orientation, competency assessment and interventions for nursing staff within a designated program. You will interface with departmental leadership, coordinate...
$263k - $360.93k
...Compliance Officer (Executive Director) Reports to Chief... ...both commercial and clinical-stage assets.... ...Menarini Stemline received FDA approval in January 20... ...to Commercial, Medical Affairs, Patient Advocacy, R&D... ...complying with its legal and regulatory obligations and...Temporary workWork at officeRemote workFlexible hours
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