Get new jobs by email
- ...support Lead on prescription management (systems and processes, ensuring monitoring is being done, support clerical staff) Actioning of MHRA safety alerts Develop and facilitate a good working relationship with community pharmacists and other local providers of healthcare...SuggestedPlacement yearLocal areaFlexible hours
- ...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...SuggestedWork 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...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- ...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
- ...governance for ERP (SAP) LIMS, MES, QMS Laboratory instruments & interfaces Lead and support regulatory audits & inspections (FDA, EMA, MHRA) Manage change control, deviation, CAPA related to validated systems Mentor and guide CSV analysts and validation teams...SuggestedContract 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...SuggestedPermanent employmentFull time
- ...a related field. 3+ years of hands-on experience in Computer System Validation within GxP-regulated environments (GCP/GMP; FDA, EU, MHRA). Able to travel up to 20% Strong practical knowledge of global regulations and guidelines, including 21 CFR Part 11, EU Annex 11, GAMP...SuggestedWork at officeLocal areaRemote workWork from homeFlexible hours2 days per week3 days per week
- ...qualification of analytical methods at CDMOsto support IND/CTA submissions in line with ICH guidelines and regulatory expectations from MHRA and FDA. Establish release and stability indicating methods for non-GMP and GMP-grade material, and oversee the qualification and...Suggested
- ...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. Interested...Suggested
$102.8k - $141.35k
...analysis. Ensure complaints are assessed for reportability under applicable regulations (e.g., FDA 21 CFR Part 803, EU MDR, CMDR, MHRA). Obtain adequate information to ensure proper documentation, investigation (including testing devices and log analysis) and closure...SuggestedWork at officeLocal areaWorldwideFlexible hours- ...Responsible for document management including scanning and archival of validation documents Familiar with data integrity guidance from MHRA and FDA Management of data integrity gap assessments and remediation Performs equipment/system/process level risk assessments per...SuggestedWork at officeLocal areaRemote workWorldwide
$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...SuggestedFlexible hours- ...Sovereign's SOPs. Expert knowledge of regulations and guidance's (e.g., 21 CFR part 11, 21 CFR part 210, 21 CFR part 211, ICH, ISPE, PDA, MHRA, PIC/S). Drive continuous improvement and preventive actions throughout the organization. Oversee the development of...SuggestedFull timeWork experience placementMonday to FridayFlexible hours
$175k - $263k
...activities related to new drug applications and other regulatory filings Represent global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc. Lead analysis to identify and address changes in global regulations including updates to SOP and process...SuggestedTemporary 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
- ...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...
- ...Responsible for ensuring the QMS supports efficient, uninterrupted operation of the facility in accordance with requirements such as FDA, MHRA, EMEA, OSHA, EPA, DEA, etc. Responsible for directing the Document Management teams involved in generation, modification, review and...Temporary workLocal areaWorldwideFlexible hours
- ...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...
- ...expertise in GMP-compliant manufacturing environments, a thorough understanding of evolving global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA), and a proven track record of leading quality transformation initiatives that deliver both regulatory confidence and...Contract workWorldwide
$125k - $150k
...centers worldwide. Several of its warehouses have been certified for pharmaceutical logistics by IATA’s CEIV Pharma and by the British MHRA. At the end of December 2023, the world's leader in airport ground services and air cargo handling, with currently around 60,000...Local areaWorldwide$90k - $99k
...inventory of licenses, renewals, and regulatory obligations. Act as the primary liaison with regulatory authorities such as the FDA, EMA, MHRA, PMDA, and other local agencies for establishment and tissue-related matters. Work with regional consultants and partners to oversee...Local area- ...-to-Have Qualifications Basic knowledge of ICH GCP and GLP regulations is a plus Experience with authority inspections (FDA, EMA, MHRA), preparation, hosting, follow-up Experience as lead auditor or co-auditor of CMOs Why us? At Tubulis, curiosity and innovation drive...Permanent employmentFull time
- ...for unlawful purposes. Consistent with the provisions of the Americans With Disabilities Act (ADA) and the Maine Human Rights Act (MHRA), and other States’ disability laws, applicants may request accommodations needed to participate in the application process. #J-188...Local areaShift 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...
- ...continued compliance Prepare, manage, and coordinate regulatory submissions (e.g., Technical Files, CE marking, UKCA, FDA submissions, MHRA notifications) for internal and external stakeholders Support internal and external audits, including notified body and regulatory...Minimum wagePermanent employmentFull timeWork at officeMonday to Friday
$120k - $150k
...risks. Knowledge of Pharmaceutical manufacturing and laboratory skills. Knowledge of global pharmaceutical regulations (i.e., EMEA, MHRA, PMDA, Health Canada, etc.). Other Requirements This is an individual contributor role and has no/some decision‑making authority....Full timeContract workFor contractorsWork at officeLocal area$180k - $210k
...from IND to Phase 2 registrational trials. Lead regulatory interactions with FDA and other global health authorities (ie FDA, EMA, MHRA, PMDA, Health Canada and other relevant agencies), including pre‑IND meetings, Type B/C meetings, and scientific advice meetings. Advise...Flexible hours- ...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
- ...and regulatory demands. Knowledge of Global PV Regulations: Ensure compliance with regulationsfrom major health authorities (e.g., MHRA, EMA, FDA, TGA, Health Canada, PMDA)through proper system configuration and governance. Governance & Oversight: Provide strategic guidance...WorldwideFlexible hours