Regulatory Submissions Manager — eCTD & IND/NDA
SK Life Science Inc
SK Life Science Inc. is seeking a Regulatory Operations Manager to lead planning and delivery of regulatory submissions (IND, NDA) and support processes for compliant, timely filings. The role requires 4–6 years of eCTD publishing experience, proficiency with standard publishing tools, and strong coordination with Clinical, Nonclinical, and CMC teams to meet health authority requirements. #J-18808-Ljbffr SK Life Science Inc
$115k - $140k
...Manager, Regulatory Operations Job Locations US-NJ-Paramus ID 2026-1... ...planning and delivery of regulatory submissions (IND, NDA, Agency Responses, others) required to... ...publishing" of documents to ensure they meet eCTD (Electronic Common Technical Document...SuggestedFull time$170k - $190k
...Summary: CMC Regulatory Affairs develops and... ...activities including IND M3/IMPD-Quality for... ...Type A, B, and C; and NDA/BLA-related... ...internal alignment, and submission logistics. Coordinate... ...deliverables in eCTD format, including... ...functional stakeholders. Manage external CMC...SuggestedTemporary workFor contractorsWork at officeFlexible hours- ...Regulatory Affairs Manager Mindlance Clinical has been providing scientific and clinical research... ...drug development planning to regulatory submissions to market, we understand it is the... ...contribute to a New Drug Application (NDA) submission, as well as other global...SuggestedPermanent employmentFull time
$170k - $190k
...Japan Summary: Nonclinical Regulatory Affairs serves as the... ...development stages, including IND-enabling, clinical development... ...scientific positions across submissions. The Associate Director/Director... ..., Type A/B/C, IND/CTA, and NDA/BLA meetings, covering...SuggestedTemporary workWork at officeFlexible hours- ...Regulatory Affairs Manager The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy...SuggestedWork experience placementWorldwide
$52.51k - $71.6k
...reconciliation, school lunch application administration, tuition contract management, and compliance-related reporting. The Specialist serves as a... ...of student enrollment data utilized for ASSA and other state submissions. Student Compliance and Reconciliation Reconcile...Full timeContract workWork at office$200k - $225k
...overseeing and directing the company's general accounting, regulatory accounting, and management & services (M&S) accounting functions. This role will... ...analysis as required. Oversee the preparation and submission of annual regulatory reports and support RRA for any other...Flexible hours- ...Rehabilitation Therapy and Nursing. Job Description Regulatory Compliance Specialist Location:... ...shipping, US Customs, and the management of DEA controlled substances. This position... ...tabulation Support activity for FDA- ACE submissions Support maintenance of various...
- ...Regulatory Submission Coordinator With minimal supervision, responsible for coordination and preparation of document packages for regulatory... ...information and respond to questions from employees, managers, vendors or customers. Ability to effectively communicate plans...Work at office
- ...Job Title: Regulatory Affairs Specialist Location: Franklin Lakes, NJ Contract... ...responsible for the support of regulatory submissions required to market medical devices in... ...improvements. · Work with Regulatory Project Manager to execute large scale projects, e.g....Contract work
- ...Regulatory Compliance Coordinator Integrated Resources, Inc is a premier staffing firm... ...clinical organization. Escalates issues to management in an expedient manner. Continually... ...regulatory documents and regulatory submissions for data accuracy, consistency, formal...
$114.6k - $189.1k
...U.S. Export Administration Regulations and for developing and managing BD’s export compliance program, while supporting overall organization... ...reviews, ECCN determinations, encryption reviews, CCAT submissions, AES audits and corresponding activities to support export compliance...Daily paidTemporary workWork at officeFlexible hours$230.3k - $368.5k
...Job Description The Senior Director of Regulatory Affairs, Digitalization, reports to the... ...Regulatory Affairs, Regulatory Affairs Management, Enterprise Excellence, and is responsible... ..., Regulatory Documentation and Submission Management, and Regulatory Information...Daily paidTemporary workWork at officeFlexible hours- ...Assurance Manager KRS CPAs, LLC is a growing CPA firm located in Paramus, NJ seeking an Assurance Manager with 7-10+ years' experience... ...with engagement team to make recommendations for any legal, regulatory and accounting issues that arise during an audit engagement...Summer holiday
- A medical device company in Hackensack, NJ is seeking a Quality and Regulatory Manager to oversee the management of Quality and Regulatory systems. The ideal candidate will possess over 5 years of experience in Quality Assurance or Regulatory Affairs within a regulated...
- ...a Grants Coordinator to effectively submit proposals for grant funding and manage various projects. Responsibilities include coordinating pre-award activities, assisting with report submissions, and maintaining post-award documents. The ideal candidate will hold a Bachelor...Full time
- ...Company, Inc. is seeking a Proposal Coordinator in Paterson, NJ, to enhance proposal development efforts. This role involves managing submission timelines, drafting content, and coordinating with team members to ensure proposals meet compliance and quality standards. The...
- ...Jersey, is seeking a leader to direct clinical and administrative quality management activities across the organization. This role oversees patient safety and compliance with accreditation and regulatory standards. The ideal candidate holds a Master’s degree in Nursing with...
$145k - $160k
...leader. It offers a full spectrum of water, waste, and energy management services, including water and wastewater treatment, commercial... ...North America. Job Description Position Purpose: The Manager, Regulatory Business - Utilities, under the general direction of the Sr....Flexible hours- Regulatory and Patient Safety Manager (Full-Time) Paterson, NJ, United States (On-site) Job Description Leads and directs clinical and administrative quality management activities for the organization, including accreditation and regulatory compliance, patient safety, and...Daily paidFull timePart timeWorldwideShift work
$120k - $130k
...clinical operations, supervise skilled nursing teams, manage high‑acuity and VIP pediatric cases, ensure regulatory compliance, and partner with leadership to... ...Monitor infection control reporting and ensure timely submission by nursing staff Ensure incident reports are...For contractorsInterim roleImmediate startRemote workAfternoon shift$21 per hour
...policy violations or concerning behavior by staff or patrons to management. Policy Adherence and Training Enforce responsible... ...incidents or concerns. Collaborate with law enforcement or regulatory bodies during investigations or audits, as necessary. Identify...Hourly payLocal areaFlexible hoursShift workAfternoon shift- ...across the behavioral health and substance use disorder portfolio managed by the company. The position expands to include authorization... ...gaps - Provide advisory support on HIPAA, audit response, regulatory inquiries, and Joint Commission / AHCA compliance posture -...Contract work
- ...investing landscape through a digitized brokerage and wealth management platform that's designed to elevate the investment experience.... ...please reach out to the recruiter. Primary Responsibilities Regulatory Examinations and Investigations Serve as the primary...Work at officeRemote work
- Quality and Regulatory Manager (Hackensack, NJ) The client is in search of a Quality and Regulatory Manager to join our growing team, responsible for the management and execution of day‑to‑day Quality and Regulatory systems. This position is a critical team member and...Work experience placement
- ...development from study design to regulatory filings and publications. The... ...analysis; • • • Regulatory submission experience is a plus. •... ...and others. • Participation in NDA submission activities as a key... ...interpersonal skills in project management, collaboration and...Interim roleImmediate startFlexible hours
- Description NEW CONCEPTS FOR LIVING (NCFL) MISSION: NCFL is dedicated to enriching the lives of adults with special needs through caring and compassionate support within a nurturing environment that promotes independence, growth, and inclusion. ESSENTIAL DUTIES...
- ...products using approved materials as appropriate Maintain accurate and timely documentation of HCP interactions in CRM systems Manage administrative responsibilities including expense reporting and activity tracking Contribute to cross-functional collaboration...Remote workNight shift
$90.17k - $112.72k
...compliance or clinical trials auditing. Skills Knowledge of regulatory standards and survey processes. Knowledge of quality improvement... ...sound professional judgment. Ability to use effective time management to set priorities, perform job related responsibilities, and respond...Full timeTemporary workPart timeLocal areaFlexible hoursShift work- ...including Behavioral Health Programs, Veterans Services, Children’s Programs, Senior and Aging Services and much more. Chart Compliance Manager SSVF Hours: Monday - Friday 8:30am - 4:30pm Location: Paterson, NJ Job Summary Supportive Services for Veteran Families (SSVF) is...Permanent employmentFull timeContract workMonday to Friday
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