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$72.12k - $108.18k
...models are developed in line with GxP , model risk management , fairness, privacy, and emerging regulatory guidance (FDA, EMA, MHRA) for AI/ML in drug development. At the Senior Scientist level, you will additionally be expected to shape scientific strategy...SuggestedTemporary work- ...coordinate interactions with FDA and international health authorities. Support clinical development across the U.S., EU/CTIS, and UK/MHRA. Partner with Clinical, CMC, and Quality teams on regulatory strategy and development decisions. Provide regulatory guidance on...Suggested2 days per week3 days per week
$187k - $281k
...2.7.4), core product information (i.e., CCDS), and local labelsRepresenting global patient safety at regulatory inspections (e.g., MHRA, FDA, EMA) Messaging and External ImpactMaintains a high degree of understanding and awareness of new and emerging clinical safety developments...SuggestedFull timeTemporary workLocal area$65.25k - $148.5k
...multi-functionally.Effectively apply knowledge of applicable internal, external, and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables.Manage and drive requests for copyrights and translations for...SuggestedH1bFlexible hours- ...expansion projects. ~ Experience with greenfield pharmaceutical manufacturing site development. ~ Experience supporting FDA, EMA, MHRA, or other regulated industry inspections and compliance programs. ~ Experience supporting regulatory remediation programs and...SuggestedContract workFor contractors
Fort Point
Richmond, VA3 days ago $215k - $235k
...execution.Health Authority EngagementServe as the primary regulatory point of contact with FDA and other global health authorities (e.g., MHRA, EMA).Lead strategic planning and preparation for regulatory interactions, including early advice engagements, platform discussions,...Suggested$105.68k - $140.91k
...Quality Management System (QMS) aligned with national and global standards and local regulatory requirements (e.g., FDA, EMA, WHO, MHRA).Ensure compliance with Good Distribution Practices (GDP) and other applicable quality standards throughout transportation, warehousing...SuggestedLocal area$198k - $235.5k
...documentation skills.Strongly prefer certified auditor credential (ASQ CQA, CBA) or equivalent qualification, experience supporting FDA and EU/MHRA inspections and partner audits, and experience supporting commercial-stage readiness in addition to clinical-stage supply.Ability to...SuggestedContract workWork at officeRemote work2 days per week- ...execution. · Responsible for ensuring efficient, uninterrupted operation of the facility in accordance with requirements such as GMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, etc. · Responsible for participating in partner, internal and regulatory inspections and audits as needed. ·...Suggested
$225k - $285k
...processes, and their outcomes remain compliant. The role will provide expert GCP guidance across global regulatory requirements (FDA, EMA, MHRA, NMPA, PMDA, etc.) and ensure compliance with ICH GCP, FDA, EMA, and other relevant global regulations. The role will collaborate...SuggestedContract workRemote work- ...regulatory submissions, registrations, renewals, certifications, and market access activities, including FDA, EU MDR, Health Canada, UK MHRA, TGA, ANVISA, PMDA, and other applicable regulatory authorities.Lead and support FDA 510(k) submissions and other regulatory filings...Suggested
$135.46k - $203.19k
...management routines.Compliance and QMS: Ensure partner adherence to cGMP/cGDP/cGLP, ICH, and relevant regional regulations (e.g., FDA, EMA, MHRA, PMDA). Maintain robust Quality Agreements and ensure effective implementation of the company’s Quality Management System elements...SuggestedFull timeContract workTemporary work$183.1k - $305.2k
...quality management systems, and inspection readiness frameworks (FDA CFR, GVP Modules)• Demonstrated experience facilitating FDA and EMA/MHRA inspections (GCP and GVP), including direct experience as an inspection point of contact• Proven track record overseeing QMP...SuggestedFull timeWork at officeWorldwide$66.6k - $133.75k
...implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits. Essential Duties and Responsibilities Applies thorough understanding of cGMP, relevant SOP...SuggestedFull timeShift work$19 - $24 per hour
...fill in-house. Serving clients in 18 Countries Successful NDA and ANDA drug registrations In good standing with the FDA, PMDA, and MHRA NOTE: Afton Scientific does not sponsor work visas. No recruiters please. Afton Scientific is seeking a dependable and detail-oriented...SuggestedHourly payContract workWork at officeVisa sponsorshipWork visa$284.63k
...advisory panels and senior governance committees.Experience with successful global regulatory filings (e.g., IND/CTA, NDA/BLA, and EMA/MHRA MAAs).Recognised expertise in pharmacovigilance regulations and methodologies, and experience contributing to external...Full timeWork at officeLocal areaRemote work2 days per week- ...pharmaceutical, biotechnology, or life sciences environment, with understanding of GxP systems, regulatory expectations (e.g., FDA, EMA, MHRA), and the interplay between cybersecurity, data integrity, and patient safety as they relate to enterprise infrastructure and...Hourly payFull timeTemporary workWork at officeLocal areaRemote workFlexible hours3 days per week
$142.4k - $213.6k
...Program: Develop, implement, and maintain the global PV audit strategy, ensuring alignment with regulatory expectations (e.g., EMA, FDA, MHRA, PMDA) and industry best practices.Manage Audit Operations: Oversee scheduling, planning, execution, reporting, and follow-up for PV...Visa sponsorshipWork visaRelocation package$140k - $155k
...Provide routine updates to GPS leadership regarding program status. Additional Responsibilities Strong understanding of FDA, EMA, MHRA, and global PV regulations. Expertise in pharmacovigilance quality systems and inspection readiness. Strong analytical and problem...Temporary workLocal areaFlexible hours$29 - $36 per hour
...fill in-house. Serving clients in 18 Countries Successful NDA and ANDA drug registrations In good standing with the FDA, PMDA, and MHRA NOTE: Afton Scientific does not sponsor work visas. No recruiters please. Afton Scientific is seeking an organized, proactive, and...Contract workWork at officeVisa sponsorshipWork visa$25 - $30 per hour
...fill in-house. Serving clients in 18 Countries Successful NDA and ANDA drug registrations In good standing with the FDA, PMDA, and MHRA NOTE: Afton Scientific does not sponsor work visas. No recruiters please. Pay Details: Non-exempt position, range of $25 - $30 per...Hourly payContract workVisa sponsorshipWork visa$284k - $302k
...Regulation (CTR) and CTA submissions.Serve as the primary regulatory contact with global health authorities (e.g., FDA, EMA, Health Canada, MHRA), leading critical interactions including meeting strategy, briefing documents, negotiations, and follow-up activities.Evaluate and...Full timeSummer workWork at officeRemote workRelocationRelocation packageShift work- ...execution. Responsible for ensuring efficient, uninterrupted operation of the facility in accordance with requirements such as GMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, etc. Responsible for participating in partner, internal and regulatory inspections and audits as needed....Contract workShift work
- ...successful candidate will be responsible for facilitating the management of sponsor audits, broad range of regulatory inspections (FDA, EMA, MHRA) and facilitating QA relationship with external clients. The position will also include conducting inspection readiness activities...Contract workWork from home
- ...are timely and compliant · Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines · Respond and interact with internal and external clients in a professional and timely manner · All other duties as assigned...Work at office
- ...preferred. Solid understanding of GDP and deviation processes . Preferred Attributes Prior exposure to regulated audits (FDA, EMA, MHRA) is advantageous. Experience in method validation or transfer projects a plus. Strong analytical thinking, data review, and...Permanent employmentFull timeContract workTemporary workAfternoon shift
- ...wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at...Temporary workFor contractorsWork at office
- ...experience in validating computerized systems. Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance. Ability to work effectively in a dynamic, cross-functional team environment. Proven expertise in applying...
$75k
...atypical results, and laboratory incidents. The role ensures investigations are performed in alignment with regulatory requirements (FDA, MHRA, EU GMP) and internal SOPs to determine root causes, assess impact, and implement effective CAPA. Responsibilities Lead and...Temporary workLive inWork at officeFlexible hours$31.35 - $38.46 per hour
...fill in-house. Serving clients in 18 Countries Successful NDA and ANDA drug registrations In good standing with the FDA, PMDA, and MHRA NOTE: Afton Scientific does not sponsor work visas. No recruiters please. Afton Scientific is seeking a motivated and detail-oriented...Hourly payContract workVisa sponsorshipWork visa
