Job Type
Date Posted
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Regulatory Submissions Manager Jobs in Maidenhead, England

74Jobs

  • 3.0
    Kyowa Hakko Kirin – Chertsey, England
    NEW
    Use and manage the electronic systems used by the Company to prepare, publish, submit and maintain regulatorysubmissions; Systems… publishing and submission of electronic documents to regulatory authorities Advise and support the Regulatory team in their preparation…
  • 3.7
    Barrington James Ltd – United Kingdom
    NEW
    Prepare and review documents for RA and EC submissions. Utilise your regulatory experience and knowledge to provide advice and… develop proactive solutions to regulatory issues and challenges. Actively manage and perform regulatory tasks for a global device…
  • 3.4
    Biogen Idec – Maidenhead, England
    NEW
    relevant regulatory authorities preferred. Experience and knowledge in the preparation of major regulatorysubmissions and supportive… implementation of regulatory strategy for assigned projects and programs. Responsible for coordinating aspects of regulatory submissions…
  • 3.7
    Pfizer – Maidenhead, England
    20 days ago 20d
    creating regulatorysubmission strategies and successful submissions. •Proven ability to manage complex lifecycle submissions using… correspondence to and from regulatory agencies and recording submission related milestones in the company's regulatory database. •Assist…
  • 4.0
    Hydrogen International Ltd – United Kingdom
    4 days ago 4d
    effective functioning of the EMEA Regulatory Affairs team with regard to all types of submissions (MAs, Renewals, Variations, PSURs… compiling, tracking, dispatching, and archiving regulatory documents and submissions in both paper, eCTD, and other electronic format…
  • 3.4
    Biogen – Maidenhead, England
    5 days ago 5d
    in preparation and execution of global regulatory strategies and to manage the submission and approval of applications for clinical… of regulatory strategy for assigned projects and programs. •Responsible for coordinating aspects of regulatorysubmissions relevant…
  • 3.4
    Three – Maidenhead, England
    4 days ago 4d
    communication skills (including experience in drafting regulatorysubmissions) and are able to put together clear and concise arguments… are able to influence, persuade and produce impactful regulatorysubmissions You can work effectively with the wider business and…
  • 2.1
    PE Global – Wokingham, England
    11 days ago 11d
    provided to German Authorities Submission of regulatory documentation and data into the German Regulatory system Managing and responding… internal electronic systems to locate regulatory documentation and data Navigate internal regulatory documentation to identify and extract…
  • 3.3
    RB – Slough, Berkshire, South East England, England
    13 days ago 13d
    renewals to the Regulatory Agency New submissions/eCTD/NeeS Extensive CMC experience for UK submission of type I and… Responsibilities Regulatory compliance for UK Marketing Authorisations in RB’s portfolio, including preparation and submission of variation…
  • 3.4
    Biogen Idec – Maidenhead, England
    16 days ago 16d
    CMC regulatory contact with relevant regulatory authorities •Coordinate all CMC aspects of global regulatorysubmissions and submission… submission strategy. *LI-EU4 Qualifications A minimum of 6-10 years strategic global regulatory CMC, or relevant experience…
  • 3.4
    Biogen – Maidenhead, England
    17 days ago 17d
    CMC regulatory contact with relevant regulatory authorities •Coordinate all CMC aspects of global regulatorysubmissions and submission… Experience and knowledge in the preparation of major global regulatorysubmissions including license applications, supplements/variations…
  • 4.6
    ProClinical Limited – High Wycombe, England
    4 days ago 4d
    provided to German Authorities Submission of regulatory documentation and data into the German Regulatory system Managing and responding… internal electronic systems to locate regulatory documentation and data Navigate internal regulatory documentation to identify and extract…
  • 3.5
    Merck KGaA – Feltham, England
    NEW
    appropriate submission support to Regulatory Affairs Associates including: Support regulatorysubmissions, approvals and… material / code To act as back up for Regulatory Affairs team for regulatorysubmissions JOB RESPONSIBILITIES Promotional…
  • 3.4
    Biogen Idec – Maidenhead, England
    16 days ago 16d
    operational activities and accuracy for submissions Serve as GEM Regulatory Lead on defined Regulatory Project Team(s), Program Teams… affiliates and distributors for effective and accurate regulatorysubmission processes, review and approval. d. Prepare and deliver…
  • 5.0
    Key People Limited – Saint Albans, England
    4 days ago 4d
    dossiers (marketing authorization applications / post-approval submissions) are prepared and dispatched on-time for products in designated… are maintained in accordance with current SOP's to fulfill regulatory obligations. -Work closely with internal and external parties…
  • 4.6
    QUANTA CONSULTANCY SERVICES LIMITED – Berkhamsted, England
    NEW
    lifecycle management of Module 2 and 3 for all regulatorysubmissions Establishing Regulatory CMC strategies Acting as the CMC representative… work for a Global Biopharmaceutical company as a Regulatory Affairs CMC Manager in Ireland. You will be responsible for managing…
  • 4.6
    Orion Electrotech Ltd – Reading, England
    4 days ago 4d
    manufacturing. Preparing regulatory documentation / dossiers for submission to Health Authorities of regulatory files such as STED and… fixed term contract basis. As a Regulatory Affairs Specialist reporting to our RA Manager you'll be responsible for preparing…
  • 3.4
    UCB – Slough, Berkshire, South East England, England
    1 days ago 1d
    as a product expert to relevant national regulatory and technology appraisal submissions Providing and contributing to scientific… , at UCB. Job Segment: Medical, Manager, Law, Project Manager, Marketing Manager, Healthcare, Management, Legal, Technology…
  • Advanced Regulatory – United Kingdom
    EASY APPLY
    1 days ago 17hr
    real opportunity to take leadership of regulatory strategy for development and MAA submissions for both Pharma and Biotech products… IIa, Phase IIb or Phase 3. This regulatory department takes the lead for EU submissions, but also has global RA positions available…
  • Advanced Regulatory – United Kingdom
    EASY APPLY
    1 days ago 17hr
    grow and develop within regulatory affairs. In the short-term you will take the lead for EU submissions for NME’s taking responsibility… development and Global submission strategies. The role: Provide EU and then global regulatory strategy guidance for NME…
  • 3.7
    Amgen – Uxbridge, England
    NEW
    Responsibilities: Strategy and Execution Plans and managesregulatorysubmissions (e.g. clinical trial and marketing applications)… Description Title (Role) Senior Manager, Regulatory Affairs Organization Global Regulatory Affairs Group Purpose…
  • 3.7
    Amgen – Uxbridge, England
    6 days ago 6d
    Responsibilities Strategy and Execution Plans and managesregulatorysubmissions (e.g. clinical trial and marketing applications)… CategoryRegulatoryJob Description Title: Regulatory Affairs Manager The company: Amgen is one of the world’s…
  • Advanced Regulatory – United Kingdom
    EASY APPLY
    1 days ago 17hr
    strategies and submissions behind them. Role: Lead regional regulatory activities and support the Global Regulatory Leader in… Affairs, RA, Regulatory jobs, RA jobs, Regulatory Affairs Jobs, Regulatory, Regulatory Affairs, Reg Affairs, RA, Regulatory jobs, RA…
  • 3.7
    Amgen – Uxbridge, England
    NEW
    Responsibilities: Strategy and Execution Plans and managesregulatorysubmissions (e.g. clinical trial and marketing applications)… Description Title (Role) Regulatory Affairs - Senior Manager Organization Global Regulatory Affairs Group Purpose…
  • 4.0
    Kite Pharma – Uxbridge, England
    2 days ago 2d
    implementation of regulatory strategies, ensuring timely preparation, review and submission of documents to regulatory authorities,… preparation and delivery of regulatorysubmissions throughout the product's life cycle from an EU regional perspective, including…
  • 4.6
    ProClinical Limited – United Kingdom
    1 days ago 23hr
    of UK/IE regulatorysubmissions, working with publishing. Management of fee request to support regulatorysubmissions in UK/IE.… Archiving of national regulatorysubmissions and approvals, both electronic and hard copy Regulatory contact point for local…
  • 3.7
    Amgen – Uxbridge, England
    NEW
    Marketing Applications as well as routine regulatorysubmissions. Manage IMPD submission and amendments in accordance with global… EURL. Provide EU regulatory input to the Global Regulatory Team (GRT) and advise early product teams on regulatory strategy with…
  • 3.3
    BD – Winnersh, England
    18 days ago 18d
    of the CE certification; Manage the resolution of roadblocks raised during the regulatorysubmission process by engaging the other… Job Description SummaryJob Description RegulatoryManager Based in Winnersh Offering a competitive salary + Bonus,excellent…
  • 3.7
    Amgen – Uxbridge, England
    NEW
    Activities Strategy and Execution Plans and managesregulatorysubmissions (e.g. clinical trial and marketing applications)… Regional Regulatory Lead (RRL), Manager Organisation Intercontinental Regional Regulatory Team Regional Regulatory Group…
  • 3.3
    Huxley Associates – Aylesbury, England
    8 days ago 8d
    ensure regulatory requirements for submissions are met and provide advice on the most efficient approaches to submissions. In addition… modules for the regulatory dossier in eCTD format, submission of variations, renewals, new licence application submissions using regional…
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