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Regulatory Affairs Director
5 days ago
Pharma Partners Recruitment Ltd Cambridge, Cambridgeshire, United KingdomSenior Regulatory Affairs Manager CMC · A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Cand ...
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Regulatory Affairs Associate Director
6 days ago
Gilead Sciences, Inc. Cambridge, Cambridgeshire, United KingdomGlobal Regulatory Affairs, Associate Director (Oncology) page is loaded Global Regulatory Affairs, Associate Director (Oncology) · Apply locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Posted 6 Days Ago job requisition id R For Current ...
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Associate Director, Regulatory Affairs
1 week ago
Relay Therapeutics Cambridge, United KingdomThe Opportunity: · We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. Y ...
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Gilead Sciences, Inc. Cambridge, Cambridgeshire, United KingdomGlobal Regulatory Affairs, Associate Director (Oncology) page is loaded · Global Regulatory Affairs, Associate Director (Oncology) · Apply locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Posted 6 Days Ago job requisition id R For Cur ...
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Gilead Sciences International, Ltd. Cambridge, United Kingdom Full timeDescription · We are looking for a driven individual who is passionate about bringing transformational medicines to those in Europe and international countries with continued unmet medical need. · This is an exciting opportunity for a Regulatory Affairs Associate Director to ...
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Regulatory Affairs Program Director M/F
1 week ago
ProductLife Group Cambridge, United Kingdom Permanent contractRegulatory Affairs Program Director M/F - 080 · Our RA teams are looking for a Program Director based in the UK to pilot and manage Regulatory Affairs outsourcing projects/programs for major clients for which specific dedicated programs and teams are put in place. · About us Gro ...
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Gilead Sciences, Inc. Cambridge, Cambridgeshire, United KingdomSenior Director, CMC Regulatory Affairs Policy, Advisory, & Intelligence page is loaded · Senior Director, CMC Regulatory Affairs Policy, Advisory, & Intelligence · Bewerben locations United Kingdom - Cambridge United Kingdom - Uxbridge time type Full time posted on Vor mehr al ...
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Director, Medical Affairs
1 week ago
Teva Pharmaceuticals Harlow, United KingdomWho we are · Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Wor ...
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Regulatory Affairs Specialist
16 hours ago
Newton Colmore Consulting Ltd Cambridge, United KingdomRegulatory Affairs Specialist - Medical Devices - Cambridge · Newton Colmore is working with a medical devices company in Cambridge who are looking to hire an experienced regulatory affairs scientist/engineer to join their team. · This role will give you an opportunity to take le ...
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Executive and Administrative Assistant
1 week ago
University of Cambridge Cambridge, United KingdomAn exciting opportunity has arisen for a highly experienced and professional Executive and Administrative Assistant to join the Office of External Affairs and Communications. · Providing a high-level executive and administrative support service, you will be required to manage the ...
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Medical Advisor
1 day ago
Mundipharma Cambridge, United Kingdom. · **Job Description**: · Background Information · Name of Employee · TBC · Date of preparation · April 2023 · Job Title · Medical Advisor · Department · Northern European Cluster (NEC) medical affairs · Location · 70% office based (Cambridge, UK with some flexible/home working) ...
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AstraZeneca Cambridge, United Kingdom**Global Commercial Marketing Opportunities - AstraZeneca** · **Gaithersburg, US or Cambridge, UK** · We have openings at the Associate Director, Director and Senior Director level. · Join our journey to become the leader in Oncology. Our pipeline is one of the deepest and broade ...
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Global Nominated Signatory
1 week ago
Cpl Life Sciences Cambridge, United Kingdom**Reference Number**: JO _3 · Global Nominated Signatory · **Rate**: Negotiable · **Job Type**: Contract · **Location**: Cambridge · Global Final Signatory - £1100 Per Day (LTD) - 6 Month Contract - Hybrid · A global pharmaceutical client of mine specialising in Oncology and Immu ...
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Associate Director Regulatory Operations
4 days ago
Bicycle Therapeutics Cambridge, United KingdomCompany Description · Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targete ...
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Solutions Compliance Specialist
1 week ago
Alchemy Global Talent Solutions Cambridge, United KingdomWe are partnering with a leading manufacturing company based in Cambridge who are seeking a Solutions Compliance Specialist to join their team. · Reporting into the Global Solutions & Support Director, you will be responsible for ensuring all legal safety requirements are met pri ...
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Medical Advisor, Haematology
5 days ago
Sobi Cambridge, United Kingdom**Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within rese ...
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Tutorial Administrator
1 day ago
Murray Edwards College Cambridge, United Kingdom**Tutorial Administrator (UG)** · **The role** · Our Tutorial Administrator will be supporting the tutorial office in to support in the administration of tasks across all aspects including welfare, exam, matriculation and graduation. They provide support to Tutors and Directors o ...
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Toxicologist
1 week ago
Thermo Fisher Scientific Cambridgeshire, United KingdomJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the r ...
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AstraZeneca Cambridge, United Kingdom**R-159981**: Associate Director, Science Communications &** E**ngagement - Clinical Pharmacology and Safety Sciences** · **Location: Cambridge, UK** · **Competitive Salary & Benefits** · At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet t ...
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Company Secretary
4 days ago
NISI Staffing Peterborough, United KingdomWe are looking for **Company Secretary & Head of Corporate Affairs** for our NHS client in **Peterborough** City Centre. · JOB SUMMARY: · The role of the Company Secretary & Head of Corporate Affairs is a pivotal one within the Trust. The post holder is a member of the Executive ...
Regulatory Affairs Director - Cambridge, Cambridgeshire, United Kingdom - Pharma Partners Recruitment Ltd
Description
Senior Regulatory Affairs Manager CMCA growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC.
The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto injector) experience.Responsibilities:
for the development and execution of global regulatory CMC and device strategies and submissions, including CMC dossiers to support clinical trial applications and marketing applicationswith internal Technical Operations colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content, responses to questions, audits and inspectionsthe preparation, drafting, review, risk analysis and mitigation planning of CMC submissions e.g.
Module 3 IND, IMPD, amendments and annual reportsRequirements:
in CMC Regulatory Affairs within the pharmaceutical or biotechnology industryand knowledge in preparation of CMC sections of INDs, CTAs, and marketing applications is requiredknowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulationsworking with recombinant proteins is highly desirableinteractions with health authorities such as scientific advice or agency meetings, including with FDA, is desirableof first degree in life sciences (or equivalent); PhD or Masters) preferred.
A highly competitive salary, stock options, annual bonus and wider benefits package is on offerTo apply for this position or hear further details then please contact Matt Thomas via matt.
Regulatory Affairs Director professionals in Cambridge
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Vidya Math
Scientific/ Clinical Trials Project Manager