Senior Director, FDA Submissions & Regulatory Compliance
Clinical Dynamix, Inc.
Clinical Dynamix, Inc. in Morristown, NJ seeks an experienced Regulatory Affairs Executive to lead FDA submissions, labeling and state licensing programs, and ensure post‑approval compliance across all products. The candidate should have 15–20 years in regulatory roles with at least 5 years in an executive capacity, deep FDA knowledge (NDA/BLA, cGMP, CMC), and strong leadership and cross‑functional collaboration. Travel 10–15% is expected. #J-18808-Ljbffr Clinical Dynamix, Inc.
$140k - $200k
Overview The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory contributor... ...deliver scientifically sound, submission ready CMC content using a risk... ...data integrity, regulatory compliance, and trust with cross functional...SeniorFull timeWork at officeLocal area- ...groups, guiding employee relations, talent acquisition, onboarding, performance management, engagement, compensation, benefits, compliance, training, and workforce planning. This role supports business priorities while fostering a positive, compliant, high-performing,...Senior
- ...insurance company is seeking an accomplished Senior Tax Director to lead and oversee its corporate tax... ...while ensuring tax efficiency and compliance. Key Responsibilities... ...regulations and applicable statutory and regulatory requirements. Manage relationships...SeniorFull timeLocal area
$121.35k - $180.85k
...backgrounds. We are seeking a talented and motivated Senior Manager or Associate Director, Compliance Americas & UK to join our team. This role will be a... ...support Compliance Fraud waste and abuse Compliance and regulatory requirements for the corporate organization. This...SeniorWork at office$220.24k - $330.36k
...count and the room to become your best, you'll find it here.Senior Director, Licensing Officer - Oncology The Senior Director, Scientific... ...U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to...SeniorContract workLocal area- ...on LinkedIn, Facebook, Instagram, Xand YouTube. The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact, moderately... ...quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances...SeniorWork at officeRemote work
- Zelis seeks a Senior Director of Pricing Solutions to lead strategic initiatives improving the performance, efficiency, scalability, and future readiness of the Claims Pricing & Revenue organization. This role collaborates with leadership to turn priorities into actionable...Senior
- Shionogi Inc. in Florham Park, NJ, seeks a Regulatory Program Support professional to manage end-to-end submission delivery, planning, and cross-functional coordination across development programs and marketed products. The role partners with the global regulatory lead,...Senior
- ...-deal intelligence to every pursuit, challenge thinking at the senior level, and know how to orchestrate diverse teams toward a common... ...- Partner with deal leadership from qualification through submission and orals, actively shaping pursuit strategy, developing win themes...SeniorWork experience placementLive inWork at officeLocal area
$105k - $115k
...Senior HR Manager – Northeast/Southeast Regions| Metro One Security ~ Onsite – Manhattan or Morristown, NJ office About us:... ...Northeast and Southeast regions. This regional leader will drive HR compliance, operational excellence, and employee engagement while...SeniorHourly payWork at officeLocal area- OrganOx is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America and oversee quality-related compliance. You will collaborate with multiple teams to ensure SaMD/SiMD products meet FDA and Health Canada requirements, including IDEs...SeniorRemote job
- A leading staffing firm is seeking a Medical Author to document clinical data and regulatory submissions to support drug development. This role requires expertise in analytical writing, project management, and collaboration with product teams to ensure high-quality deliverables...Senior
- ...transformationMinimum of 1 year of experience serving utilities clients (electric, gas, or water) or in a utilities finance, controllership, or regulatory function.Bachelor's degree or equivalent (minimum 12 years' work experience). If Associate’s Degree, must have equivalent minimum...SeniorWork experience placementLive inWork at officeLocal areaShift work
$150k - $180k
...Senior Manager/Associate Director of Accounting About Kalaris Kalaris Therapeutics is a clinical stage biopharmaceutical company dedicated... ...operations, monthly financial close, SEC reporting, SOX compliance, stock-based compensation, and financial systems administration...SeniorWork at office- Cain Consulting Group, LLC is seeking an experienced HR Manager to oversee the full employee lifecycle and serve as a trusted advisor to leadership. The role requires hands-on involvement in recruiting, onboarding, employee relations and offboarding, as well as benefits...Senior
- ...Overview Responsible for all regulatory affairs activities required... ..., and submit regulatory submissions to FDA including supplements, and... ...state licenses regulatory compliance. Primary Duties & Responsibilities... ...in collaboration with the Director of Compliance Collaborate...Senior
- ...diverse candidates, and guide processes from screening to hire. You’ll build knowledge of positions, draft pre-screening questions, and ensure compliance with employment laws. This role supports college recruiting and ambassador programs. #J-18808-Ljbffr FirstEnergy Corp.Senior
- Dun & Bradstreet in Florham Park, NJ seeks a Senior Director, People Business Partner to align people strategies with sales and revenue objectives. You will lead a team of People Business Partners, drive organization design, and leverage AI tools to deliver insights and...Senior
- ...industry. Purpose of the Job Doceree is seeking a hands-on Senior Manager - HR Operations & HRIS to lead the execution of U.S.... ...activities and strengthen HR operations, processes, and compliance. Working closely with HR leadership, global teams, and implementation...SeniorWorldwideFlexible hours
$74.8k - $183.9k
...ADP is hiring a Senior Technical Product Manager. ADP is building a next-generation AI-native HCM platform for small businesses. We are rethinking what payroll, HR, and compliance software looks like when it is designed from the ground up with Generative AI technology...SeniorMinimum wageFull timeTemporary workLocal areaDay shift$97.3k - $133.82k
Senior Associate Brand Manager, Ritz Innovation### Senior Associate Brand Manager, Ritz InnovationApply: East Hanover, New Jersey, United... ...R&D, Operations, Finance, Sales, Legal, Pack, Insights, and Regulatory to drive innovation projects forward* Collaborate with the...SeniorFull timeRelocation package$224.24k - $336.36k
...real difference, there’s only one choice.Senior Director, Head of US Site Management The Senior... ...approaches aligned to study needs and regulatory expectations;Provide strategic and... ...mitigate site-level operational, quality, compliance, budget, timeline, and resourcing...SeniorLocal area$165k - $185k
General Information LocationWhippany, New Jersey Working Schedule Full-Time Work Arrangement Hybrid Travel Required 25% Relocation Assistance Available No Grade 14I Posted Date 02-Oct-2026 Job ID 20889 Description and Requirements...SeniorFull timeTemporary workWork at officeLocal areaRelocation package3 days per week- ...can lead projects and teams and have strong communication, people and executive presence skills that help you build credibility with senior client executives.The Work:Build an advisory relationship with strategic accounts and engage with Architects, Chief Technology...SeniorWork experience placementLive inWork at officeLocal area
$160k - $190k
Overview The Associate Director, GCP Quality Assurance provides senior-level quality oversight for Shionogi’s clinical development activities, ensuring compliance with ICH, FDA, EMA, PMDA, MHRA, and other global regulatory requirements. Serving as the QA representative...Full timeWork at officeLocal area2 days per week3 days per week- Sanofi Morristown, NJ, seeks an Associate Director of Managed Care Operations to lead cross-functional initiatives spanning CMS... ...and Data Science to drive AI-enabled efficiency and ensure regulatory compliance across complex programs. Key responsibilities include shaping...
$140k - $170k
Overview The Senior Manager, Regulatory Affairs CMC supports the CMC... ...of the Senior Director, CMC. In this role,... ...authorities to ensure compliance and drive the success... ...preparation, review, and submission of CMC‑related... ...development (e.g., FDA, EMA, ICH). Excellent...SeniorFull timeLocal areaWork from home2 days per week3 days per week$70k - $150k
...American Investigations, Diligence and Compliance - Specialist practice is seeking an Associate... ...the client or taking direction from a senior member of the Financial Investigations... ...complex investigations, forensic accounting, regulatory compliance, internal (client)...Temporary workInterim roleFlexible hours- ...agenda in the age of AI.Role Overview:As an HR Transformation Senior Manager, you will lead and shape how organizations approach HR... ...global clients and knowledge of international HR practices and compliance.Agile & Scrum Certification:Certification in Agile or Scrum methodologies...SeniorLive inWork at officeLocal area
$204.4k - $379.6k
...innovation intersect. As Senior Director, US Risk Management &... ...safety governance, FDA engagement, and risk... ...platforms) to ensure compliance, high quality... ...oversee timely, accurate submission of US aggregate reports... ...Authority requests. 4. Regulatory Compliance & Quality...SeniorFull timeWorldwideRelocation package
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, FDA Submissions & Regulatory Compliance. Be the first to apply!
- senior manager legal Convent Station, NJ
- senior performance engineer Convent Station, NJ
- remote senior business analyst Convent Station, NJ
- senior performance tester Convent Station, NJ
- senior Convent Station, NJ
- senior manager diversity & inclusion Convent Station, NJ
- senior financial analyst fp&a Convent Station, NJ
- senior application security Convent Station, NJ
- senior application administrator Convent Station, NJ
- senior activities Convent Station, NJ




