Regulatory Affairs Associate — FDA Submissions & Strategy
Azurity Pharmaceuticals - US
Azurity Pharmaceuticals seeks a Regulatory Affairs Associate/Senior Associate to assist in preparing, reviewing, and submitting regulatory filings to the FDA and global agencies. You will contribute to lifecycle management of IND, NDA, ANDA, and related activities across product lines. You will collaborate with Technical Operations, Quality Assurance, Clinical Development, and Medical Affairs to ensure compliant submissions and timely regulatory decisions while maintaining meticulous records and #J-18808-Ljbffr Azurity Pharmaceuticals - US
- ...specialty pharma company, is seeking a Regulatory Affairs Associate/Senior Associate to support... ...lifecycle management. You will work with FDA and global agencies, ensure regulatory... ...guide cross‑functional teams through submissions in a fast‑paced environment. You'll report...Suggested
- ...team. #CloroxIsThePlace ( The Regulatory Affairs Specialist II provides... ...compliance and safety of Clorox's FDA-regulated Foods portfolio,... ...early and propose mitigation strategies. Support licensing... ...Halal, Organic). Coordinate submission dossiers, data verification,...Suggested
- 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...SuggestedFull time
- ...and regions. Summary: Plasma Regulatory Affairs oversees the licensing,... ...other regulatory activities associated with Source Plasma collection... ...Food and Drug Administration (FDA) licensure and registration... ...review prior to application submission. Research internal documents...SuggestedWork at office
- Regulatory Affairs Associate/Senior Associate Azurity Pharmaceuticals is a privately held,... ...assist in preparing, review and submission regulatory filings to the FDA and other global health agencies... ..., and influence regulatory strategy to key stakeholders. Physical...Suggested
- ...and around the world. Regulatory Affairs Consultant, In Silico... ...of regulatory strategies and objectives that result... ...support of all regulatory submissions. Serve as the... ...contact with the US FDA to achieve company regulatory... ...level. Pharmatech Associates, Inc. provides equal...Local areaRemote work10 hours per week
$51 per hour
...Regulatory Affairs SpecialistMaxonic maintains a close and long-term relationship... ...activities for existing US FDA class III medical devices.... ...and authoring regulatory submissions to providing critical input... ...teams and developing regulatory strategy, this role is an excellent...Local area2 days per week3 days per week- Grifols seeks a Regulatory Affairs professional in Clayton, NC to implement global registration strategies, ensuring compliance with labeling requirements for product shipments... ...various departments to manage regulatory submissions effectively. Qualified candidates should...
- ...organizes and implements strategies and activities required to procure regulatory approval for new and... ...and prepares regulatory submissions, including 510(k) premarket... ...and updates US FDA product listings and establishment... ...-5 years of regulatory affairs experience in the...Full timeTemporary workMonday to FridayDay shift
- ...Strategic Client Advisory: Analyze diverse client portfolios to structure and implement high-level wealth preservation and protection strategies. Open Architecture Distribution: Dynamically quote, underwrite, and secure coverage utilizing our multi-carrier platform to...Contract workWork at officeImmediate startRemote work
- ...Regulatory Affairs SpecialistAssist Regulatory Personnel with the Completion of Work Packages for... ...Meeting Requests and Briefing Packages for FDA meetings, Investigational New Drug... ...of exp in A: Regulatory Affairs B: FDA submissions C: IND / BLA D: CMC documentation E: Labeling...Remote work
- ...supporting our comprehensive fleet safety management strategy, while ensuring compliance with all applicable... ..., Risk Management, Worker’s Compensation) and regulatory stakeholders. Direct Company activities associated safety incident management oversight; investigation...Hourly payWork experience placementLocal area
- ...Coordination, Installation Coordination, Finance, and other departments as needed. Support vendor onboarding, GC prequalification submissions, and track approval status. Maintain compliance tracking reports and provide status updates to leadership. Identify...Temporary workFor contractorsWorldwide
- ...Assist in the preparation, review, and submission of FATCA and CRS filings, ensuring compliance with regulatory requirements and reporting deadlines Review investor and entity documentation to determine FATCA/CRS classifications and identify reportable accounts Perform...InternshipWork at office
- ...Supporting the client in all aspects of safety submission Supports the Submission Manager in... ...knowledge and understanding of global regulatory reporting requirements to ensure... ...Providing support in all PV operations associated with Safety Reporting Performing Quality...Work experience placement
- Mahogany Premium Home Inspections is seeking a licensed North Carolina home inspector to join our growing Charlotte-area team. You will perform residential inspections to the highest standards and deliver clear, thorough reports that clients can trust. We value professionalism...
$55k - $85k
Job Description Guardian Real Estate Inspections, LLC is seeking a Licensed North Carolina Home Inspector to perform high‑quality residential inspections, deliver clear and defensible reports, and provide an excellent client experience. This position offers flexible scheduling...Full timePart timeRemote workFlexible hours$47.7k - $83.48k
...in this class are responsible for the American Correctional Association (ACA) accreditation and PREA audits at the facility. This position... ...and Standards and other Division Directors to develop strategies for enhancing prison operations, using the results of operational...Work experience placementWork at officeTrial periodFlexible hoursNight shift- 247Hire is seeking a Certification Specialist to support and drive the execution of the NC Medicaid MES certification strategy across projects in Raleigh, NC. The role partners with business leads, project teams, and vendors to ensure CMS criteria are met and certification...
$47.7k - $83.48k
...Compliance Manager, The Division Audit Administrator, Director of Performance and Standards, and other Division Directors to develop strategies for enhancing prison operations, using the results of operational audits, and other measures developed by this section. Knowledge...Trial periodNight shift- Grifols, S.A. is seeking a Plasma Regulatory Affairs Associate to oversee licensing, surveillance, and regulatory activities for Source Plasma in the United States, Canada and ROW. The role focuses on FDA licensure, CLIA, and COLA requirements, with responsibilities spanning...Work at office
- BCG Attorney Search seeks a Healthcare Associate to join its Life Sciences Team in Raleigh, North Carolina. The successful candidate will handle regulatory work and assist clients in the healthcare industry, using their expertise in life sciences law. Applicants should...
- Grifols seeks a Regulatory Affairs professional to manage regulatory submissions and licensing activities across the US, Canada, and ROW. You will prepare applications, monitor submissions, and communicate regulatory requirements to internal teams. You will collaborate...
- US Inspect US Inspect is the nations leading inspection services firm, delivering residential inspections since 1987. We have openings for experienced NC licensed inspectors to join our team of highly skilled inspectors. Home Inspector Our inspectors are more ...Extra incomeTemporary workWork at office
- Licensed State Motor Vehicle Inspector/Lube Technician Ready to get your automotive career moving? At Premium Velocity Auto/ Jiffy Lube (PVA), your State Motor Vehicle Inspector's License will make your career and earning potential limitless! We are seeking a Licensed...Full timeTemporary workLocal areaFlexible hours
- ...Ensures subcontracting strategies align with project goals and company policies. Reviews and interprets prime contract requirements to ensure subcontract compliance. Manages and is responsible for the Small Business Program. Timely submits Individual Subcontracting Reports...Contract work
- ...Technical Director in maintaining a compliant Quality System under FDA 21 CFR and GDP. The role leads supplier and internal audits,... ...assessments, KPI tracking, and quality documentation to ensure regulatory compliance. The candidate will manage distributor...
- ...Stryker is seeking a Staff Regulatory Affairs Specialist, ( Pharmaceutical... ...standards and options of regulatory submissions, approval pathways, and... ...regarding submission strategies, regulatory pathways, submission... ...4 years of experience in an FDA-regulated or other highly regulated...For contractorsLocal area
- Job Description Job Description Licensed North Carolina Home Inspector Focused Property Inspections | Raleigh • Fayetteville • Jacksonville • Wilmington Focused Property Inspections (FPI) is growing across North Carolina, and we are hiring a licensed NC Home ...Full timeWork at officeLocal area
- Guardian Real Estate Inspections, LLC is seeking a Licensed North Carolina Home Inspector to conduct high-quality residential inspections and deliver clear, defensible reports. The role offers flexible scheduling, a hybrid work environment, and potential for long-term growth...Flexible hours
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