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- ...Regulatory Affairs Specialist - NMPA This position will partner with the in-country RA team as well as the Product Localization Engineering (PLE) and other cross-functional supporting teams, make sure the company's regulatory affairs activities are conducted in accordance...SuggestedFor contractorsLocal area
- ...year experience with operating laboratory or manufacturing equipment. Tissue Sectioning and Staining. Experience working in regulated environment (OSHA, NMPA, FDA, etc). Regards, Aequor Technologies LLC 377 Hoes Lane, Suite 300 Piscataway, NJ 08854 #J-18808-Ljbffr AequorSuggestedContract workAfternoon shift
- ...Anhang I Vorbereitung und Neueinreichung von internationalen Produktregistrierungen von Primärpackmitteln (US FDA, Health Canada, NMPA (CFDA), CDSCO, etc.) Unterstützung bei der Umsetzung regulatorischer Anforderungen über die gesamte Prozesskette für Bestandprodukte...SuggestedHome officeFlexible hours
$134k - $231.15k
...is maintained in compliance with ISO 13485 and ISO 14971 processes. Stay current with global regulatory changes (EU MDR, FDA, China NMPA, etc.) impacting EMC and safety compliance and communicate updates to internal stakeholders. Support regulatory submissions and...SuggestedTemporary workLocal areaFlexible hours- ...deviations. \* \*\*Regulatory Compliance:\*\* Ensure all clinical trial activities comply with local regulatory requirements (e.g., NMPA), ethical guidelines, and Lilly's Standard Operating Procedures (SOPs). Prepare and submit necessary regulatory documents. \* \*\*Team...SuggestedContract workWork at officeLocal area
$200k - $250k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview Of...Suggested$136k - $160k
...investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview Of...SuggestedContract work$134.5k - $158k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of...SuggestedWork at office$148k - $174k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview Of...SuggestedShift work$200k - $300k
...global regulatory strategies to achieve rapid approvals for investigational and marketing plans from agencies such as FDA, EMA, PMDA, NMPA (CHN) Perform research to drive development of regulatory strategy for the assigned clinical development program Lead and drive...SuggestedSystimmune
Princeton, NJ11 days ago$90k - $130k
...data integrity, traceability, and compliance Support internal QA audits, external audits, and regulatory inspections (e.g., FDA, EMA, NMPA) Contribute to IND, CTA, and other regulatory submission documents related to bioanalysis and clinical pharmacology Translational...Suggested- ...procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. Specialist ensures timely and high-quality...SuggestedTemporary workWork experience placementWork at officeRelocationFlexible hours3 days per week
- ...input and guidance to cross‑functional partners regulatory documentation for medical device approvals in compliance with EU MDR, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other relevant regulatory bodies and/or Distributors. Develop regulatory strategies for new product...SuggestedWork at officeLocal areaWorldwide
- ...of regulatory dossiers, including FDA 510(k), De Novo, EU MDR Technical Documentation, Health Canada license applications, ANVISA, NMPA, CDSCO, TGA, and other international filings. Develop and execute regulatory strategies for new product development, AI/ML‑enabled...SuggestedFull timeTemporary workPrivate practiceWorldwideFlexible hours
- ...not limited to, 21 CFR Part 820, ISO 13485, MDSAP country related requirements TGA, ANVISA RDC 665, CMDR, MHLW MO 169, IVDD, IVDR, NMPA, TAIWAN-MEDDEV-QMS. Ability to travel domestically and internationally up to 15% annually; scheduled day travel to Fremont, Lodi,...SuggestedWork experience placementLocal areaImmediate startNight shift
- ...Engagement Lead strategy development, preparation, and cross‑functional alignment for key Health Authority interactions (FDA, EMA, PMDA, NMPA, etc.) related to metabolic disorders, including protocol advice, CV safety considerations, efficacy endpoints, long‑term safety...Flexible hours
$244.11k - $295.81k
...Mastery, but not limited to GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11, 312, 812, 820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, and ICH guidelines to ensure compliance and quality across investigational use only assay programs. Communication & Collaboration:...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...product performance attributes.* Author platform rationale documents supporting regulatory submissions across regions (FDA, EMA, PMDA, NMPA).* Monitor regulatory landscape for combination products; partner with Regulatory Affairs to understand strategy and participate in...Full timeContract workH1bVisa sponsorshipWork visa
- ...readiness strategy and planning for clinical trial submission across multiple agencies including, but not limited to FDA, MHRA, and NMPA.* Knowledge and demonstrated experience in application of risk-based quality principles (e.g. QbD) in a pharmaceutical environment*...Remote jobContract workWork experience placementSummer workWork at officeFlexible hours2 days per week
$126k - $204.6k
...manufacturers. Familiarity with combination product regulatory pathways, CDER/CBER coordination, and global requirements (FDA, EMA, PMDA, NMPA). Strategic and commercial acumen: connecting technical decisions to portfolio and business outcomes. Other Information Travel: 1...Full timeContract workFlexible hours$122k - $194k
..., such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA’s guidance documents, and including requirements that are relevant to the overall...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$35 - $40 per hour
...testing, heavy metals, pesticide limits). Navigate TCM-specific regulations (e.g., USP Herbal Compendium, WHO guidelines, China NMPA standards). Address challenges in botanical adulteration, safety data, and traditional use claims. Education and Experience Requirements...Part timeFixed term contractHuisong Pharmaceuticals
Santa Ana, CA25 days ago$201.17k - $321.88k
...provide recommendations. Coordinates and leads audit activities with all global regulatory agencies (e.g. FDA, Notified Bodies, PMDA, NMPA etc.) Creates and maintains Compliance department internal methodology and procedures that comply with applicable domestic and...Full timeLocal areaRemote workWorldwide- ...technical and business process solutions to complex problems ~ Knowledge of global medical device regulatory requirements (FDA, Anvisa, NMPA, MDR) and quality standards (ISO, GB, JISC) ~ Complete understanding of medical device project management principles, theories &...Work at officeRemote workShift work
BD
Sandy, UT14 days ago $128k - $192k
...development principles, industry best practices, and regulatory expectations (including those of US FDA, EMA/NBs, UK MHRA, and China NMPA). Effective communication with stakeholders and a commitment to sharing knowledge for mutual growth are essential. You will join...- ...scientific literature search and interpretation. Familiarity with IVD product development processes and regulatory requirements (NMPA, FDA, IVDR) preferred. Experience ~ Minimum of 2-3 years of laboratory or R&D experience in the IVD industry preferred. Benefits...Flexible hours
- ...tools. Navigate and understand the quality system and escalate issues Accurately performs tasks in a regulated environment (OSHA, NMPA, FDA, etc.) Performs and documents all transactions and production instructions with accuracy related to the proper receipt,...
$108k - $176k
...other regulatory authorities. Have experience with submissions including human factors data outside the US, such as EMA, MHRA, PMDA, NMPA, etc. Have experience in and enjoy managing people, focusing on their development. Have experience with a wide variety of...Local areaMonday to Friday$65 per hour
...end traceability. Regulatory Reference: Articulate and apply CDISC documents and international regulatory guidance (FDA, PMDA, NMPA) as active reference tools during the study lifecycle. Standards Governance: Provide "consultant-level" guidance to cross-functional...Hourly payContract workTemporary workFor contractorsWork experience placementRemote work- ...~Navigates and understands the quality system and escalate issues. ~Accurately performs tasks in a regulated environment (OSHA, NMPA, FDA, etc.). ~Performs and documents all transactions and production instructions with accuracy related to the proper receipt, quarantine...
