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Senior Director, Regulatory Strategy Lead
Found in: Jooble UK O C2 - 6 days ago
IQVIA LLC Reading, Berkshire, United KingdomSenior Director, Regulatory Strategy Lead (home-based) page is loaded · Senior Director, Regulatory Strategy Lead (home-based) · Apply locations Reading, Berkshire, United Kingdom Solna, Sweden Belgrade, Serbia Tartu, Estonia Vienna, Austria time type Full time posted on Posted ...
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Senior Director, Regulatory Strategy Lead
Found in: Jooble UK O C2 - 6 days ago
IQVIA Argentina Reading, Berkshire, United KingdomJob Overview · Provide leadership and advice on the development of optimum regulatory strategies for drug development, product lifecycle management and portfolio management, particularly focused on emerging biopharmaceutical company customer goals in oncology. Provides strategic ...
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Project Manager
Found in: SonicJobs Direct Apply UK - 13 hours ago
White Label Recruitment Reading, United Kingdom Full timeWhite label Recruitment are excited to be working with an extremely reputable and market leading manufacturing company. The company are an HVAC contractor, specialising in Ventilation and Smoke & Fire Safety. They're now seeking a Project Manager to join the team. · Their busine ...
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Marketing Specialist
Found in: SonicJobs Direct Apply UK - 4 days ago
Focus Resourcing Group Reading, United Kingdom Full time12-Month FTC, maternity cover · This is an exciting role working for a highly successful healthcare company where you will be responsible for marketing, event and reporting assistance for the Projects team and the wider Business Development team. · Our client is looking for a can ...
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Senior Performance Engineer
Found in: SonicJobs Direct Apply UK - 5 days ago
Canadian Solar SSES (UK) Ltd Reading, United Kingdom Full timeSr Performance and Service Engineer · e-STORAGE is a subsidiary of Canadian Solar and a leading company specializing in the design, manufacturing, and integration of battery energy storage systems for utility-scale applications. The Company offers its own proprietary LFP battery ...
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Study Project Lead, Associate Director, Single Sponsor Dedicated
Found in: Jooble UK O C2 - 6 days ago
IQVIA Argentina Reading, Berkshire, United KingdomJob Purpose · The Senior Study Leader is the leader of the cross-functional clinical trial team (CTT), guides planning and management of the assigned clinical study/studies end-to-end to achieve objectives. Accountable for proactive, iterative operational planning with effective ...
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Study Project Lead, Associate Director, Single Sponsor Dedicated
Found in: Talent UK C2 - 4 days ago
IQVIA Reading, United Kingdom Full timeJob Purpose · The Senior Study Leader is the leader of the cross-functional clinical trial team (CTT), guides planning and management of the assigned clinical study/studies end-to-end to achieve objectives. Accountable for proactive, iterative operational planning with effective ...
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Lead Director
Found in: Jooble UK O C2 - 5 days ago
GlaxoSmithKline Brentford, Greater London, United KingdomWe're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we're building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it'll be one of the ...
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Directorate Lead Pharmacist for Trauma and Orthopaedics
Found in: Talent UK C2 - 4 days ago
Oxford University Hospitals NHS Foundation Trust Oxford, United Kingdom PermanentJob summary · An exciting opportunity has arisen to be the directorate pharmacist for Trauma & Orthopaedics at Oxford University Hospitals. You will have the opportunity to lead a pharmacy team providing a clinical services to Trauma & Orthopaedics services cross-site. The post ...
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Global Regulatory Affairs Strategist
Found in: SonicJobs Direct Apply UK - 3 days ago
Randstad Tech IT Maidenhead, United KingdomAre you an experienced Regulatory Affairs Strategist? Are you interested in being the Regulatory Representative for assigned due diligences, under the direction of the Global Regulatory Strategy Lead? If so, our Biotechnology client is looking for individuals just like you · The ...
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Audit & Accounts Senior
Found in: SonicJobs Direct Apply UK - 13 hours ago
Curtis Recruitment Maidenhead, United Kingdom Full timeWe are recruiting for an Audit & Accounts Senior on behalf of a successful, four-partner, boutique accountancy practice that is enjoying a period of continued growth. You will be joining an Audit & Accounts team that has recently progressed a team member to Manager, hence the nee ...
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Technical Sales Executive
Found in: SonicJobs Direct Apply UK - 6 days ago
ETS Technical Selection Oxford, United Kingdom Full timeTechnical Sales Executive/PHYSICS (Scientific Measurement Instruments) - Oxfordshire, UK · Basic salary £35-50,000 per annum (depending on experience) · A new vacancy for a Technical Sales Executive (PHYSICS/ELECTRONICS) with leading manufacturer of precision measurement instrum ...
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Technical Sales Executive
Found in: SonicJobs Direct Apply UK - 5 hours ago
ETS Technical Selection Oxford, United Kingdom Full timeTechnical Sales Executive (GEOSCIENCE/GEOPHYSICS) - Oxfordshire, UK · Basic salary £35-50,000 per annum (depending on experience) · A new vacancy for a Technical Sales Executive (GEOSCIENCE/GEOPHYSICS) with leading manufacturer of precision measurement instrumentation used for b ...
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Hotel Operations Manager
Found in: SonicJobs Direct Apply UK - 21 hours ago
James Webber Recruitment Basingstoke, United KingdomHotel Operations Manager - Near Basingstoke Hampshire · The property: · Set in landscaped grounds with stunning views, this stunning converted manor house offering elegantly appointed rooms, stunning contemporary food and a strong business mix offering · The Role: · Hotel Operat ...
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Estimator
Found in: SonicJobs Direct Apply UK - 5 days ago
Bennett and Game Recruitment LTD West Wycombe, United Kingdom Full timeEstimator required to join an industry leading construction specialist in Buckinghamshire. The company work on architectural glass projects across the UK and due to continued growth, require an Estimator to join their team. · Estimator Position RemunerationSalary £30,000 - £40,00 ...
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Senior Maintenance Engineer
Found in: SonicJobs Direct Apply UK - 5 days ago
Science and Technology Facilities Council (STFC) Didcot, United Kingdom Full timeSenior Maintenance Engineer (HVAC) · Science and Technology Facilities Council · Salary: £42,840 - £47,124 per annum (dependant on experience) · Contract Type: Open Ended (Permanent) · Location: Rutherford Appleton Laboratory, Didcot, Oxfordshire, OX11 0QX · Closing Date: 6th May ...
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Head of Vehicle Inspections
Found in: SonicJobs Direct Apply UK - 13 hours ago
Dekra Automotive Ltd High Wycombe, United Kingdom Full timeHead of Vehicle Inspections & Audits · Location: Nationwide/hybrid · Salary: Up to £75k per annum DOE, Plus Bonus · Contract: Full time, Permanent · Benefits: 25 days annual leave plus BH's, Holiday buy and sell scheme, Employee referral scheme, Private health insurance, 5% Pensi ...
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Field Service Engineer 400
Found in: SonicJobs Direct Apply UK - 13 hours ago
Omega Resource Group Watford, United Kingdom Full timeJob Role: Field Service Engineer · Location: Watford · Salary Range: £40,000 - £42,000 (Base), £54,000 - £57,000 (including OTE) · Our client, a leading global supplier of equipment and services to packaging and label manufacturers, is on the lookout for talented and ambitious F ...
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Associate Architect
Found in: SonicJobs Direct Apply UK - 6 days ago
Hunter Mason Consulting Oxford, United Kingdom Full timeJob Title: Associate Architect · Location: Oxford (with work in London Office as required) · Salary: £60,000 per annum · Company Overview: Join a leading architectural firm operating in Oxford and London, committed to delivering innovative and sustainable design solutions. They s ...
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Design Manager
Found in: SonicJobs Direct Apply UK - 13 hours ago
ERNEST AND FLORENT LTD Windsor, United Kingdom Full timeA highly technical Design Manager, who has an abundance of construction Fit Out experience, is now needed to join a hungry, ambitious, and pro-active construction organisation. · The Design Manager will be based across London and Berkshire. · The Design Manager Role · The succes ...
Scientific Team Lead/Scientific Director - Reading, Berkshire, United Kingdom - IQVIA LLC
Description
Senior Director, Regulatory Strategy Lead (home-based) page is loaded Senior Director, Regulatory Strategy Lead (home-based)Apply locations Reading, Berkshire, United Kingdom Solna, Sweden Belgrade, Serbia Tartu, Estonia Vienna, Austria time type Full time posted on Posted 6 Days Ago job requisition id R Job Overview
Provide leadership and advice on the development of optimum regulatory strategies for drug development, product lifecycle management and portfolio management, particularly focused on emerging biopharmaceutical company customer goals in oncology.
Provides strategic regulatory advice towards efficient clinical development and navigation of US & European regulatory frameworks. Responsible for the development of regulatory business, in accordance with RADDS and Corporate business plans. Participates in project-related work, as necessary.Provide scientific, regulatory, and product development leadership and consultancy expertise to support strategic business activities and investment opportunities.; Provide thought leadership in regulation of bio-pharmaceutical products by preparing publications, white papers, and blogs in areas of expertise and by participating in scientific conferences and webinars, as appropriate.
Integrate strategic regulatory & drug development support services into emerging biopharmaceutical company clinical trial offerings.Interface with clients in collaboration with existing Therapeutic Science & Strategy Unit Centres of Excellence to provide strategic advice and incorporate regulatory guidance.
Support engagements with regulatory authorities (e.g., Lead assessments of risk and probability of regulatory success and development of mitigations for candidate pharmaceutical products, including providing regulatory contributions to indication prioritization exercises, development strategy evaluations and gap analyses, due diligence, and similar activities.Support the innovative development of compounds to maximize technical, regulatory, and commercial success, including contribution to the development of Target Product Profiles (TPPs), Clinical Development Plans (CDPs), clinical study designs, synopses, and protocols, as appropriate.
Strategic leadership of the development of regulatory submissions, including INDs, marketing/licensing authorizations (NDA/BLA/MAAs), special designations (orphan drugs, pediatrics plans, "fast-track", "break-through" etc...).
Ensure high-quality, well-reasoned, objective deliverables (using data-driven design, where available and appropriate) that meet the highest standards of medical, ethical and scientific integrity and conduct.
Assume the role of customer senior management as requested, including membership of virtual cross functional drug development teams.Provide regulatory strategy expertise to support strategic business activities and investment opportunities.
Ensure Customer Satisfaction by working closely with Senior Management, CRO Operations, Therapeutic Units, and other Operations Heads to ensure optimum strategic consultancy to customers.
Provide internal and external strategic regulatory and pharmaceutical development-related educational services in support of all branches of IQVIA business.
Attend key scientific meetings/conferences and keep abreast of relevant scientific publications to maintain awareness of current scientific developments and progress in regulatory strategyDevelop and maintain ongoing relationships with pharmaceutical and biotechnology companies, key opinion leaders
Compliance with all business office requirements for tracking of time and effort.
Relevant s cience degree & post graduate specialization or equivalent experience in medicinal product development and regulatory strategy.
Strategic regulatory experience in novel oncology investigational product development to registration including interactions with US and European regulatory authorities.
Prior regulatory authority experience desirable.Typically requires years relevant clinical research and/or regulatory experience with multi-regional and global focus including significant experience in senior strategic role, including specific oncology investigational product experience
Requires broad management and leadership knowledge to lead multiple job areas, the ability to influence others to accept practices and approaches.
Expertise in Excel and PowerPoint.Client-focused and consultative approach for project management - not just an order taker, but is able to suggest alternate approaches and provide strategic insights that meet client needs.
Has a strong commitment to quality.Has the desire to develop and mentor junior staff.
LI-remote
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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locations 7 Locations time type Full time posted on Posted 20 Days Ago IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward.
Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.