Hybrid Regulatory Affairs Associate — IND/NDA Submissions
RXinsider LTD.
Azurity Pharmaceuticals is seeking a Regulatory Affairs Associate/Senior Associate to join its Regulatory Affairs team. You will assist in preparing, reviewing and submitting regulatory filings to the FDA and global health agencies, and manage the lifecycle of IND, NDA, and ANDA programs. You will collaborate with Technical Operations, Quality Assurance, Clinical Development and Medical Affairs to ensure timely submissions, maintain records, and provide regulatory guidance on post-approval #J-18808-Ljbffr RXinsider LTD.
- ...description: As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will... ..., review and submission regulatory filings to... ...managing lifecycle of IND, NDA, ANDA, etc. The Regulatory... ...balance with our hybrid work model, allowing...SuggestedLive inWork from home
- ...Regulatory Affairs Specialist Peregrine Team is seeking a Regulatory Affairs Specialist to support global regulatory submissions and ensure compliance across pharmaceutical products. This role... ...and submit regulatory filings (IND, NDA, BLA, etc.) Track and interpret...Suggested
- State Employees' Credit Union in North Carolina is seeking a Regulatory Compliance Analyst to help ensure adherence to applicable laws and... ...in training material reviews, and support metric reporting. Hybrid in-office/remote work is available to balance collaboration with...SuggestedWork at officeRemote work
- ...and around the world. Regulatory Affairs Consultant, In Silico... ...regulatory strategy from pre‑IND to launch,... ...support of all regulatory submissions. Serve as the primary... ...following registrations NDA’s, ANDA’s, IND’s and... ...management level. Pharmatech Associates, Inc. provides equal...SuggestedLocal areaRemote work10 hours per week
- ...to manage day-to-day import/export tasks and ensure adherence to CBP, FDA and EAR rules. The role is on-site in Columbus, OH with hybrid flexibility of 2-3 days on-site. Responsibilities include ISA program support, HS codes management, FTZ operations, and document validation...Suggested
- ...description: As a part of the Regulatory Affairs team at Azurity, the... ...Authority (HA) submissions for US and for Canada... ...filings including IND, NDA, ANDA, NDS, DMF for a... ...and manage timelines associated with regulatory submissions... ...balance with our hybrid work model, allowing...Live inWork from home
- ...organization. As a part of the Regulatory Affairs team at Azurity, the... ...Authority (HA) submissions for US and for Canada... ...filings including IND, NDA, ANDA, NDS, DMF for a... ...and manage timelines associated with regulatory... ...key stakeholders. #LI-Hybrid #LI-Full-time Physical...Full timeContract workFor contractorsFor subcontractorLive inWork from home
- ...coordinate, review, and audit grants under IIJA Weatherization and IRA HOMES/HEAR programs. This time-limited, full-time role includes hybrid telework and state benefits. Responsibilities include financial oversight, invoicing, reporting, and governance of subgrants/...Full timeWork at officeRemote work
- ...Therapeutics, Inc. in Raleigh, NC seeks an Associate Director/Director/Sr. Director, Regulatory CMC to lead global CMC regulatory... ...of biologics. You will guide submissions, risk mitigation, and cross-... ...drives CMC strategies across INDs, BLAs, and post-approval changes,...
$28 - $30 per hour
...HCR0003161 Title - Regulatory Affairs Specialist Location - Remote Pay Rate - $28-3... ...Investigator's Brochure, harmonization request, IND Safety Reports). • ssist Regulatory... ...of exp in A: Regulatory Affairs B: FDA submissions C: IND / BLA D: CMC documentation E:...Remote work- ...Administration Job Classification Title Insurance Regulatory Analyst Manager (NS) Position Number 600... ...This position currently qualifies for a hybrid telework option with routine office and... ...examinations, and facilitating the submission of required reports and filings. Provide...Work at officeRemote workFlexible hoursNight shift
- North Carolina Department of Insurance seeks an Insurance Regulatory Analyst II (NS) to review rate, rule, and form filings for property... ...accuracy, proper rating principles, and statutory compliance. Hybrid telework with routine office and up to one remote workday per week...Work at officeRemote work
- ...Incredible opportunity to shape global regulatory strategy and deliver breakthrough science... ...effectiveness, process efficiency, and submission readiness. • Prepare and deliver strategic... ...of product development, including IND/BLA/MAA submissions, global registration...Work at officeRemote workWork from homeWorldwide
- ...compliant, scalable contract implementations and support public records requests related to the pilot. The role requires paralegal experience or a related degree with substantial contract work, and offers the potential for hybrid #J-18808-Ljbffr Health & Human ServicesContract work
- Fortrea in Durham, NC, is looking for a Compensation Analyst to support the Regional Manager of Compensation. This hybrid role focuses on data collection, salary surveys, job evaluations, and report preparation to drive market pricing decisions. You will participate in...
$150k - $180k
...capabilities in Commercial Due Diligence (CDD) and PE Consulting Services. Title: Sr Manager - Commercial Diligence Location: Raleigh, NC (Hybrid) Salary: $150,000 to $180,000 + 50% BonusWhat people are saying: Proper work life balance Be a part of a build out of a core...- ...bonds matters, coordinating with district attorneys to prosecute cases, and representing the department in litigation and regulatory matters. Hybrid telework is available with up to one remote day per week. The ideal candidate holds a J.D. #J-18808-Ljbffr State of...Remote work1 day per week
- ...and optimize data exchange across health information systems. Hybrid work arrangement in the Raleigh area is supported. The role requires... ...with clinical stakeholders to ensure data quality and regulatory compliance. You will lead analyses and develop training materials...
- Solesis is seeking a full-time Regulatory Affairs Specialist for Quality Assurance in Winston-Salem, NC. The candidate will plan and implement strategies for obtaining regulatory approval for medical devices, ensuring compliance with US, EU, and international standards...Full time
- ...processes, validate data, and ensure timely submissions across federal, state, and supplemental... ...and state agencies. The position is hybrid and based at the RTP, NC headquarters, with... ...contract reporting, while maintaining strict regulatory adherence. #J-18808-Ljbffr GrifolsContract work
- ...description As a part of the Regulatory Affairs team at Azurity, the... ...regulatory applications such as INDs, NDAs, BLAs, including ISS... ...required to support 505(b)2) NDA submissions Authoring, preparation and... ...work‑life balance with our hybrid work model, allowing you to...Work at officeWork from home
$81.07k - $129.71k
...mathematics, statistics and business principles to provide actuarial support within a team of actuaries. The position operates in a Hybrid-Flex environment with in-person collaboration two days a week and remote work flexibility. Competitive salary ranges from $81,068...Remote workFlexible hours2 days per week- ...healthcare data into actionable insights to improve affordability and inform strategic decisions, leveraging BI tools and SQL in a hybrid-flex environment from Durham, NC. You should have a bachelor’s or higher degree, 4+ years actuarial experience, and progress toward...Flexible hours
- ...analyses, and present actionable insights to leadership to support liquidity goals. The role requires strong Excel/PowerPoint skills, experience with budgeting and forecasting, and the ability to work in a hybrid environment with cross-functional teams. #J-18808-Ljbffr SECUContract work
- ...translating performance data into actionable financial insights, enabling better decision-making, and driving success for patients and markets. The position offers a hybrid work environment and competitive compensation with additional benefits. #J-18808-Ljbffr Strive Health, LLCRemote job
- Eaton's Raleigh, NC-based hybrid IT Risk and Compliance Manager leads global IT controls, SOX program, and risk governance. Focus on ITGCs and Oracle/EBS/EPM platforms; partners with acquisition/divestiture teams to design controls and drive improvements. Role emphasizes...
- Chiesi USA is seeking a Regulatory Affairs (RA) Manager with strong CMC pre- and post-approval experience... ...Rare Diseases portfolio. The role is hybrid, based in Cary, NC, and requires leading CMC regulatory activities across submissions worldwide. The candidate will author/...Worldwide
- ...Research A great place to work. Careers At Elder Research Current job opportunities are posted here as they become available. Workplace: Hybrid - Due to in-office requirements, candidates must be local to either Raleigh, NC or Charlottesville, VA. Relocation assistance is...Work at officeLocal areaRelocation package
- The Association in Durham, NC, seeks a Lead Manager - Tax to oversee US tax compliance for the Association and related entities with a hybrid work schedule. You will report to the Director - Tax & Compliance and supervise one Specialist, coordinating with internal and external...
- A leading biopharmaceutical company is seeking an Associate Director/Director of Regulatory CMC to manage CMC functions and ensure compliance with global... ...multiple projects effectively. This role offers a hybrid work environment and opportunities for professional growth...Remote job
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