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$44.9k - $74.95k
...audits by providing accurate and complete documentation. Ensure stability program compliance with global regulatory bodies (FDA, EMA, MHRA) . Deviation, CAPA & Investigations Document and track stability‑related deviations (e.g., missed pulls, chamber excursions)....SuggestedFull time- ...adherence to regulatory guidelines on Electronic Records, Signatures, Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, and MHRA. Develop protocols to demonstrate compliance and address gaps. · Lead risk assessments, gap analyses, and deviation management...Suggested
- ...activities by helping map timelines, organize source documentation, and review key regulatory guidance excerpts (e.g., ICH E2A-F, FDA/EMA/MHRA requirements). Assist with safety database-related tasks (e.g., Argus demo/screenshot‑based exercises, basic data quality checks,...SuggestedSummer workInternshipRemote work
- ...You? Basic Qualification Bachelor's degree 5+ years of experience in Quality roles OR in a highly regulated environment (EMA/ FDA/ MHRA) and manufacturing operations Large Molecule experience Preferred Qualification Problem solving and negotiation skills Ability...SuggestedLocal area
- ..., disability, protected veteran status, gender identity or any other factor protected by applicable federal, state, or local laws. MHRA is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation...SuggestedFull timeLocal area
- ...Guidelines ICH Q7, Q8, Q9, Q10 (Quality Risk Management, Pharmaceutical Quality Systems) Other Regulatory Bodies (as applicable) MHRA (UK), Health Canada, TGA (Australia), PMDA (Japan), etc. Ensure alignment with data integrity guidance (FDA, MHRA, PIC/S). Maintain...SuggestedWork experience placementWork at office
- ...and Vision coverage with employer contribution through Anthem. 14.5% of your annual salary contributed to your retirement fund by MHRA each year. 12 paid holidays. 15 paid sick days and 10 vacation days. Long Term Disability coverage. Employer provided Life Insurance...SuggestedFull timeLocal area
- ...for‑service, Milestone‑Based, FTE‑Based Pricing) is strongly preferred. Familiarity with GMP and regulatory requirements (FDA, EMA, MHRA) strongly preferred. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions...SuggestedContract workWork experience placementRemote work
- ...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...SuggestedPermanent employmentFull timeContract workTemporary workAfternoon shift
$97.74k - $122.77k
....gov, CDC, Bureau of Labor Statistics, ClinicalTrials.gov, FDA’s 510(K) Premarket Notifications and Registrations, EUDAMED, and the MHRA Public Access Registration Database) to conduct quantitative analyses and assess population demographics, disease prevalence, healthcare...SuggestedWork at office- ...regulatory demands. Knowledge of Global PV Regulations: Ensure compliance with regulations from major health authorities (e.g., MHRA, EMA, FDA, TGA, Health Canada, PMDA) through proper system configuration and governance. Governance & Oversight: Provide strategic...SuggestedFlexible hours
- ...Experience with clinical audit, incident reporting, or complaint handling Familiarity with medical device regulations (particularly MHRA reporting) or quality management standards Experience using support or ticketing tools in a customer-facing context What Do We...SuggestedHome office
$240k - $275k
...alignment with overall regulatory and clinical strategy. Lead preparation for and participation in key regulatory interactions (FDA, EMA, MHRA, PMDA, and other agencies). Clinical Operations Partnership & Trial Execution Partner with Clinical Operations leadership to...SuggestedLocal area$190k - $269k
...required.* Working knowledge of supporting inspection preparation and inspection activities for global regulatory filings (US FDA, EMA, MHRA, PMDA, and ANVISA desired).* Experience in supporting regulatory health authority inspections, including preparation, documentation...SuggestedContract workFor contractorsWork experience placementWork at officeLocal areaFlexible hours- ..., disability, protected veteran status, gender identity or any other factor protected by applicable federal, state, or local laws. MHRA is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation...SuggestedFull timeApprenticeshipLocal area
$99.3k - $198.7k
...regulatory authorities and notified bodies as needed. Ensure timely reporting to regulatory authorities (e.g., FDA, EMA, Health Canada, MHRA). Monitor recall effectiveness and conduct recall effectiveness checks. Track and report compliance metrics and KPIs to leadership...Worldwide- ...progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the...Remote workFlexible hours
- ...life sciences, engineering, regulatory affairs, or related field) or equivalent experience. Demonstrated experience with GMP, FDA, MHRA, EMA and other regulatory agency requirements for pharmaceutical validation and operations, analytical and stability functions. Experience...Local areaRemote work
$206k - $229k
...comprehensive knowledge of USFDA 21 CFR regulations Part 11: EC/ER requirements, GMP requirements of various regulatory bodies - USFDA/ MHRA/ EU GMP/ PMDA. Strong comprehensive knowledge of ICH Guidelines, FDA and Health Canada Regulations. Strong comprehensive knowledge...Flexible hours- ...Equipment process and framework knowledge. Have working knowledge of basic hand tools. Basic computer skills. Knowledge of cGMP, FDA, MHRA and DEA guidelines and how to apply them effectively. Knowledge of Solid Dosage manufacturing preferred. Must be able to manage...Local areaShift work
- ...investigations, annual review, retain samples, and instrument calibration and main point of contact for internal and external audits (e.g. FDA, MHRA, and GMP‑A). Basic Qualifications Bachelor’s Degree + 4 years relevant pharmaceutical experience Associate’s degree + 6 years...Local area
- ...Knowledge and experience of clinical and commercial systems supporting GCP compliance with US and global regulations (FDA, EMA, ICH, MHRA, etc.). GLP experience a plus. Able to provide solution‑minded approach and flexibility to emerging challenges. #J-18808-Ljbffr...
$59.9k - $120.45k
...validation activities comply with: FDA (21 CFR Part 210/211) EU GMP / Annex 1 ICH guidelines Maintain inspection readiness for FDA, MHRA, and other global regulatory audits. Review and approve validation protocols, reports, SOPs, and change controls. Project &...Full timeWorldwide$105 - $175 per hour
...sponsor and CRO. Regulatory Compliance Advisory: Provide expert guidance on global pharmacovigilance regulatory requirements (FDA, EMA, MHRA, ICH) to ensure the new CRO setup and safety database configuration meet all applicable standards for current and planned clinical...Hourly payWork at officeRemote work- ...covering GxP and related quality systems. Establish global audit policies, procedures, and methodologies aligned to EMA, ICH, FDA, MHRA, and other regulatory requirements. Ensure alignment of audit activities with enterprise risk management and quality management systems...Permanent employmentFull time
$56.95k - $95k
...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. Responsibilities Takes lead role on new equipment validation. Writes protocols, reports (...Shift work- ...progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the...
$120k - $155k
Lead regulatory strategy and submission activities for Qnovia's drug-device combination products across FDA, MHRA, and other global regulatory bodies. About the Role Qnovia is advancing a portfolio of drug-device combination products through regulatory pathways in the...Local areaFlexible hours£43k - £73.5k per year
...requirements. TMF Reference Model and risk‑based TMF management principles. Experience with inspection readiness activities (FDA, EMA, MHRA, etc) and TMF audits. Procedural gap analysis and issue resolution in TMF contexts. Experience with leading eTMF platforms (e.g.,...Contract workLocal area- ...appropriate documentation and sign‑off for deviations Lead or assist in pre‑inspection readiness for regulatory audits (e.g. FDA, EMA, MHRA) Track findings, respond to audit reports, manage CAPAs through resolution and effectiveness checks, and ensure timely completion...Work at officeRemote work