CMC Regulatory Affairs Specialist I - Drive FDA Submissions
Piper Companies
Piper Companies is seeking a Regulatory Affairs Specialist I – CMC to support our end client's Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team. This position is onsite in Research Triangle Park (RTP), NC. The successful candidate will manage CMC regulatory documents and submissions, requiring 2-3+ years of experience in the pharmaceutical or biotechnology industry. The role focuses on ensuring accuracy and compliance with FDA regulations while working collaboratively with cross-functional teams. #J-18808-Ljbffr Piper Companies
- ...Associate Director, Regulatory Affairs (CMC) Department: Regulatory Employment... ...global regulatory dossiers. Drive regulatory interactions with... ...development, including pre‑submission meetings, responses to information... ...authorities beyond US FDA is preferred. Knowledgeable...SuggestedFull timeTemporary workWork at officeHome officeFlexible hours
- ...and around the world. Regulatory Affairs Consultant, In Silico... .... Develop, lead, and drive the execution of the regulatory... ...of all regulatory submissions. Serve as the primary... ...contact with the US FDA to achieve company... ...Check all that apply: * CMC and Product...SuggestedLocal areaRemote work10 hours per week
- ...Summary Piper Companies is seeking a Regulatory Affairs Specialist I – CMC to support our end client's... ...manage CMC regulatory documents and submission workflows. Support preparation and maintenance... ..., complete, and compliant with FDA regulations and internal timelines....SuggestedHourly payWork at office
$28 - $30 per hour
...HCR0003161 Title - Regulatory Affairs Specialist Location - Remote Pay... ...and Briefing Packages for FDA meetings, Investigational New... ...Applications (Labeling, Efficacy, and CMC), Pediatric Study Plans,... ...Regulatory Affairs B: FDA submissions C: IND / BLA D: CMC...SuggestedRemote work- ...Summary Teleflex is investing in its ability to drive material cost improvement opportunities as... ...generating significant stakeholder value. The Senior Regulatory Affairs Specialist will develop strategies and regulatory submissions for Material Cost Improvement Projects (CIP)...SuggestedShift work
- 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
- ...activities required to procure regulatory approval for new and revised... ...and prepares regulatory submissions, including 510(k) premarket notifications... .... Prepares and updates US FDA product listings and... ...Minimum of 3–5 years of regulatory affairs experience in the medical...Full timeTemporary workMonday to FridayDay shift
- Grifols, located in Research Triangle Park, NC, seeks a Plasma Regulatory Affairs Associate. The successful candidate will oversee regulatory... ...include preparing applications, monitoring submissions, and educating internal teams on regulatory requirements. A...
- Summary Plasma Regulatory Affairs oversees the licensing, surveillance, and other regulatory activities... ...with US Food and Drug Administration (FDA) licensure and registration (biologics... ...for review prior to application submission. Research internal documents, complete...Work at office
- ...Incredible opportunity to shape global regulatory strategy and deliver breakthrough science... ...closely with Global Regulatory Leads to drive globally aligned regulatory plans, guide... ...effectiveness, process efficiency, and submission readiness. • Prepare and deliver strategic...Work at officeRemote workWork from homeWorldwide
$20.85 per hour
...to confirm applicant's knowledge of NC Motor Vehicle laws, identification of road signs, checking vision and observing/evaluating driving skills by riding with the customer in their personal vehicle on a road test in all types of weather. You will serve as a public advisor...Hourly payPermanent employmentTemporary workWork experience placementWork at officeMonday to FridayNight shift- ...driver‑license categories. Verify applicant knowledge of North Carolina motor‑vehicle laws, road‑sign identification, vision, and driving skills. Enter accurate applicant and court‑ordered data into internal systems. Provide public advisory services regarding health...Work at officeMonday to FridayNight shift
$39.24k - $68.68k
...You will provide first-class customer service while confirming applicants' knowledge of motor vehicle laws and assisting them during driving tests. A Bachelor's degree or equivalent experience is required, alongside a valid North Carolina Driver License. The position...- ...licenses, ensuring high-quality customer service. Responsibilities include confirming knowledge of motor vehicle laws and assessing driving skills. A valid Class C North Carolina Driver License is required, and candidates will undergo a background check. The role...
$19.8 - $22.9 per hour
...licensed, service-driven, and love connecting-this is your moment to Belong to Something Beautiful. Key Responsibilities Drive results Help achieve store goals by providing and rebooking beauty services, servicing clients, and selling products Perform...Hourly payPermanent employmentFull timePart timeFlexible hoursShift workNight shiftWeekend work- ...program for an established federally registered investment advisor (RIA) and registered broker-dealer, and drive adherence with applicable laws, regulations, and regulatory guidance. Our ideal candidate has a strong, working knowledge of the compliance responsibilities of...Temporary workLocal areaImmediate startFlexible hours
$105.79k - $141.05k
...for what's next, where performance, security, and resilience matter. This is a high accountability environment where bold ideas drive real innovation for our customers, partners, and industry. The work is challenging, expectations are clear, and trust is built into...Temporary workFor contractorsRemote work- ...Cardinal Health is looking for a Sr Regulatory Affairs Specialist to provide regulatory expertise for medical devices. This remote position involves supporting a diverse portfolio and ensuring compliance with regulations while collaborating with internal teams. The ideal...Remote work
$61.81k - $84.99k
...products. This role oversees licensing, reporting, recordkeeping, audits, and internal compliance processes related to DEA and other regulatory agency requirements. The position partners cross-functionally with quality, operations, supply chain, legal, and commercial teams...Work experience placementWork at officeLocal areaWorldwideFlexible hours- ...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 have 3-5 years...
- ...analytics in support of executive and business teams. Responsibilities include authoring reports and analyzing customer feedback data to drive improvements. The ideal candidate will possess strong analytical skills, attention to detail, and proficiency in Excel and...
$61.81k - $84.99k
Henry Schein is searching for a Compliance Specialist in North Carolina responsible for maintaining compliance with federal and state regulations concerning controlled substances and regulated products. The ideal candidate will have 1-3 years of experience, preferably...- Crandall Corporation is seeking a Safety/Health/Environmental Specialist in Raleigh, NC. This role involves driving, compliance, and administrative tasks requiring excellent social skills and attention to detail. The ideal candidate will help in developing safety and health...
- Grifols seeks a Regulatory Affairs professional in Clayton, NC to implement global registration strategies, ensuring compliance with labeling... ...with various departments to manage regulatory submissions effectively. Qualified candidates should have a Bachelor’s...
$101.25k - $136.5k
...Practice (CIS), is all about embracing digital transformation by driving core modernization holistically across layers. We help... ...Compliance, Security, and operational teams to ensure alignment with regulatory standards. Support interpretation and application of HIPAA...Temporary work$61.81k - $84.99k
...products. This role oversees licensing, reporting, recordkeeping, audits, and internal compliance processes related to DEA and other regulatory agency requirements. The position partners cross-functionally with quality, operations, supply chain, legal, and commercial teams...Work experience placementWork at officeLocal areaWorldwideFlexible hours- 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
- A state office in North Carolina is seeking a Program Coordinator I to serve as a Driver License Examiner, responsible for administering tests and ensuring adherence to DMV policies. The ideal candidate will have strong customer service skills, a valid North Carolina Driver...Hourly payTemporary workWork at office
- ...Peregrine Team is seeking a Regulatory Affairs Specialist to support global regulatory submissions and ensure compliance across pharmaceutical products. This role will... ...regulatory experience in pharma/biotech ~ Knowledge of FDA and international regulatory guidelines ~...Full time
- Introduction At IBM Legal, Regulatory Affairs & General Counsel, we provide the guidance and oversight that enable IBM to innovate responsibly... ...requirements to inform change to compliance mechanisms driving improvements to productivity, efficiency and quality of outcomes...Worldwide
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