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Director of Regulatory Affairs
1 week ago
Blackfield Associates Reading, United KingdomJob Description · Our client, a pharmaceutical development company has a requirement for a Regulatory Affairs Director to join their UK team. This role is perfect for a senior manager/ experienced regulatory professional who is looking to head up Strategy implantation with focus ...
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Director of Regulatory Affairs
1 week ago
Blackfield Associates Reading, Berkshire, United KingdomOur client, a pharmaceutical development company has a requirement for a Regulatory Affairs Director to join their UK team. This role is perfect for a senior manager/ experienced regulatory professional who is looking to head up Strategy implantation with focus of the UK and EU m ...
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Director of Regulatory Affairs
6 days ago
Blackfield Associates Reading, Berkshire, United KingdomJob Description · Our client, a pharmaceutical development company has a requirement for a Regulatory Affairs Director to join their UK team. This role is perfect for a senior manager/ experienced regulatory professional who is looking to head up Strategy implantation with focus ...
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Director of Regulatory Affairs
2 weeks ago
Blackfield Associates Reading, Berkshire, United KingdomOur client, a pharmaceutical development company has a requirement for a Regulatory Affairs Director to join their UK team. This role is perfect for a senior manager/ experienced regulatory professional who is looking to head up Strategy implantation with focus of the UK and EU m ...
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Science and Regulatory Director
1 week ago
IQVIA Argentina Reading, Berkshire, United KingdomPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs · Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Re ...
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Associate Director,/director Global Regulatory
9 hours ago
GSK Brentford, United Kingdom**Site Name**: USA - Pennsylvania - Upper Providence, Rockville Biopharm, UK - London - Brentford · **Posted Date**: Jan · Are you a Regulatory Affairs professional looking to expand your career in Precision Medicine and Digital Health? If yes, then this Associate Director/Direc ...
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Associate Director, Regulatory Operations
1 week ago
Adaptimmune Abingdon, United Kingdom**Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K. and biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and all ...
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Adaptimmune Abingdon, United Kingdom**Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of ...
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Johnson & Johnson High Wycombe, United KingdomThe Janssen EMEA Regulatory Affairs team is looking to recruit an **EU Regulatory Affairs Expert **within the **Neuroscience, Cardiovascular, Metabolism **, **and Retinal (NCM&R) **therapy area team. We are looking for an Associate Director in Regulatory Affairs to provide strate ...
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Johnson & Johnson High Wycombe, United KingdomFor Johnson & Johnson's Global Regulatory Affairs team, we are currently hiring an Associate Director of Global Regulatory Policy & Intelligence (GRPI) that can be based in any of our J&J/Janssen hubs in EMEA. We believe in strong team collaboration both locally and globally, whi ...
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Iqvia Reading, Berkshire, United KingdomThe Associate Director – Regulatory Submissions · The Associate Director – Regulatory Submissions is responsible to lead a worldwide Regulatory Submissions delivery team within IQVIA Translations. This team is in charge of the development and harmonization of the Regulatory Subm ...
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Senior Director, Regulatory Affairs
1 week ago
Transcrip Partners Wokingham, Berkshire, United KingdomtranScrip is a leading drug development partner who, in the last 2 decades, has supported over 500 clients deliver many development programmes and regulatory submissions. · tranScrip has an excellent reputation for providing strategic regulatory support and for delivering regula ...
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Senior Director Regulatory Affairs
1 week ago
Transcrip Partners Wokingham, Berkshire, United KingdomtranScrip is a leading drug development partner who, in the last 2 decades, has supported over 500 clients deliver many development programmes and regulatory submissions. · tranScrip has an excellent reputation for providing strategic regulatory support and for delivering regula ...
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Director of Regulatory Affairs
2 weeks ago
TMC Pharma Services Ltd Hartley Wintney, Hampshire, United KingdomCompany Description · TMC Pharma Services Ltd, located in Hartley Wintney, provides a full range of expert support services to the pharmaceutical industry. Our highly qualified team specializes in drug development from preclinical to post approval, regulatory affairs, drug devel ...
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Senior Director, Regulatory Affairs
1 week ago
tranScrip Limited Wokingham, United Kingdom permanentDuties and responsibilities · Applicants will have extensive experience in all or most of the following areas: · Provide regulatory affairs expertise to clients seeking regulatory strategic input to their development programmes. · Applies senior regulatory affairs experience in ...
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Senior Director, Regulatory Affairs
4 days ago
tranScrip Limited Wokingham, United Kingdom permanentDuties and responsibilities · Applicants will have extensive experience in all or most of the following areas: · Provide regulatory affairs expertise to clients seeking regulatory strategic input to their development programmes. · Applies senior regulatory affairs experience in ...
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Director Regulatory CMC
1 day ago
Bristol Myers Squibb Uxbridge, United Kingdom Full timeDescription · The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute the strategies in alignme ...
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Executive Assistant to General Counsel
2 weeks ago
Three Reading, United KingdomOur people make us who we are. We're a diverse and inclusive bunch, and it's important you can feel you belong here. We value everybody for who they are and what they bring to the table, supporting one another as we continue to deliver for our customers. · At Three we have a hybr ...
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South Central
6 days ago
Chemistree Berkshire, United KingdomPackage: Negotiable competitive basic salary, bonus, car allowance and additional benefits package · Location: Hybrid working - 2 days home-based with 3 days in the office - office location Slough or Paddington · Role Type: Regulatory Affairs, Regulatory Affairs Manager, Senior R ...
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Compliance Manager
2 weeks ago
eFinancialCareers Reading, United KingdomA UK law firm that are renowned for providing career development, are currently looking for a compliance Manager to join their team to help to enhance and develop their compliance programme. · In this role you will be responsible for the firm's compliance and regulatory commitmen ...
Science and Regulatory Director - Reading, Berkshire, United Kingdom - IQVIA LLC
Description
Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA page is loaded Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEAApply locations Reading, Berkshire, United Kingdom Solna, Sweden Amsterdam, Netherlands Barcelona, Spain Sofia, Bulgaria time type Full time posted on Posted 7 Days Ago job requisition id R Prepares and/or reviews regulatory documents to support clinical trial submissions.
Independently provides regulatory support for complex projects and programsActs as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer
Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications
May provide support on key regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs)
Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
Deliver regulatory training/presentations as required, internally or externallyMay mentor junior colleagues and engage in department knowledge sharing
Good understanding of the regulations, directives and guidance supporting clinical Research and Development
Demonstrates comprehensive regulatory/technical expertise
Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
Ability to work on several projects, retaining quality and timelines and can prioritize workload
Strong mentoring skills, helping junior colleagues and setting a positive example
Strong software and computer skills, including MS Office applications
Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9 + years' experience* (*or combination of education, training and experience)
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Travel might be required
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
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