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VP - Clinical Development - Oncology
Permanent / North London, London
VP - Global Clinical Development - Oncology A UK-based senior strategic leadership opportunity, working at an established mid-sized Global pharmaceutical business with a longstanding presence and extremely busy future in Oncology. Acting as the Global R&D head for all Phase I-II programs, you will line manage a highly skilled team of MDs / PhDs with clinical and industry expertise in Oncology. This team is based across multiple sites, and each report will act as a Study Director of global cross-functional project teams, ultimately meaning your own overall workflow oversight is of a group nearing 100 staff. This role will naturally work very closely with fellow VPs and department heads of other Global functions such as Discovery Medicine, Clinical Operations, Regulatory Affairs, Biostatistics and Drug Safety. This person will act as a true champion of all things early phase clinical development in Oncology for this organisation. Key responsibilities include: Act as a member of the Global R&D leadership team for Oncology, making and executing strategic decisions that impact important clinical trial programs Lead the early phase focused Oncology clinical research team, driving project decision-making and helping team members and cross-functional colleagues to reach key business objectives Design and oversee development of Regional and Global clinical trial plans and protocols Lead interactions with partners on drug development collaborations, both within industry and academia Managing on-going dialogue with regulatory bodies for all early phase clinical trial programs (e.g. FDA, EMA, MHRA) Manage departmental and project-based reviews, ensuring efficient running of trials and cross-functional teams as per GCP and internal company SOPs Candidate requirements include: Qualified physician (MD, MBBS, MBChB or equivalent) PhD qualified candidates will also be considered, assuming they offer all of the experience listed below An experienced pharma industry drug development expert with a significant number of years working in Study Director level roles at a Global level Phase I-II clinical research experience is essential Significant experience of working closely with regulatory bodies such as the FDA and EMA Line management experience of R&D teams across different locations/territories is required Oncology experience is required - it is highly advantageous to bring this from both pre-industry roles (e.g. clinical medicine, academia) and in-industry roles Experience of working on R&D partnerships, bringing molecules together as potential double or triple combination therapies A vocal and passionate communicator, who will be proud and loud to lead early phase Oncology clinical development for this business To apply for this position please use the "Easy Apply" option or feel free to send your CV directly to the Pharma-Partners team via email info@pharma-partners.co.uk
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Regulatory Affairs Associate Director, Global Labelling
Permanent / Oxfordshire, England
Job title: Regulatory Affairs Associate Director, Global Labelling A Biopharmaceutical company in Oxfordshire are seeking a Regulatory Affairs Associate Director, Global Labelling. Reporting directly into the Head of Global Labelling, this role will be responsible for both technical and operational support within Labelling across global markets. Responsibilities: Manage quality control over entire labelling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution Under the direction of the Head of Global Labelling, assist in implementing process improvements to increase the efficiency and effectiveness of the label review process Provide project management to the Labelling Team throughout the entire process, from the decision to update a CCDS/USPI/SPC through notification to stakeholders Lead the development of CCDS, package inserts and equivalents and their associated Patient Labelling Documents Support the Head of Global Labelling in providing development and guidance to Labelling Managers and Senior Labelling Managers. Requirements: Proven experience in regulatory affairs with particular focus on labelling Experience associated with global product labelling regulations strongly desired Ability to review regulatory labelling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies Salary and benefits: A competitive salary, annual bonus and wider benefits package in on offer with this role To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk
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Regulatory Affairs Manager, Labelling
Permanent / Oxfordshire, England
Job title: Regulatory Affairs Manager, Labelling A Biopharmaceutical company in Oxfordshire are seeking a Regulatory Affairs Manager, Labelling to join their Operations team. This role will have responsibility for preparing labelling documents for submission and implementation globally. Responsibilities: Manage quality control over entire labelling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution Assist in implementing process improvements to increase the efficiency and effectiveness of the label review process Responsible for proofreading and departmental QC work, including during the Linguistic Review stages for EU language translations. Participate in the maintenance of Labelling documents with regard to CMC and technical changes in alignment with requirements and in support of the Labelling content leads. Requirements: Proven experience in regulatory affairs with particular focus on labelling Experience associated with global product labelling regulations strongly desired B.S/B.A. (or equivalent in industry related experience) Ability to review regulatory labelling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies Salary and benefits: A competitive salary, annual bonus and wider benefits package in on offer with this role. To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk
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Regulatory Affairs Manager, Global Publishing
Permanent / Oxfordshire, England
Job title: Regulatory Affairs Manager, Global Publishing A Biopharmaceutical company in Oxfordshire are seeking a Regulatory Affairs Manager, Global Publishing to join their Regulatory Operations team. This role will be responsible for the preparation and publishing of documentation for commercial and development submissions to global health authorities. As a manager, you will be expected to provide project leadership and submission oversight of various products. Responsibilities: Collaborating in submission teams, to plan and execute timely regulatory submissions primarily in eCTD format in support of investigational and marketed products Represent Global Regulatory Operations on regulatory teams and project teams as a subject matter expert Monitors global health authority regulations, guidelines, and specifications including FDA, EMA, Health Canada, and ICH for regulatory submissions to ensure compliance Maintain records and data in Regulatory Information Management (RIM) system Requirements: Minimum 4-6 years of Regulatory Operations experience required, 1-2 years of direct management experience preferred Requires knowledge of global health authority regulations, guidelines, and specifications including, EMA, Health Canada, FDA and ICH Technical experience in handling eCTD Publishing tools and Submission portals is required. Experience with ISIToolBox, GlobalSubmit Review and Publish, Starting Point templates, DocuSign, and Veeva Vault is preferred Experience in managing and publishing of major regulatory submissions for investigational or marketed products to global health authorities in eCTD format. Salary and benefits: A competitive salary, annual bonus and wider benefits package is on offer with this role To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk
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Regulatory Affairs Senior Associate, Global Publishing
Permanent / Oxfordshire, England
Job title: Regulatory Affairs Senior Associate, Global Publishing A Biopharmaceutical company in Oxfordshire are seeking a Senior Associate, Global Publishing to join their Regulatory Operations team. This role will be responsible for the preparation and publishing of documentation for commercial and development submissions to global health authorities. Responsibilities: Support Regulatory Affairs team in planning, publishing, submission, and archive of regulatory documents. Prepare and publish regulatory submissions in eCTD format, including, but not limited to: amendments; supplements; periodic/annual reports; promotional materials and meeting packages. Work across company disciplines and represent Global Regulatory Operations on assigned project and/or task teams to effectively communicate and drive timings and deliverables. Maintain records in Regulatory Information Management (RIM) system. Requirements: Direct experience with publishing, compiling, preparing and QC of documents for eCTD submissions. Demonstrates a working knowledge of Regulatory Information Management system and publishing technologies. Experience with Global Submit Review/Publish, ISIToolBox, Starting Point templates, and Veeva Vault a plus. 3+ years of Regulatory Operations experience preferred. Salary and benefits: A competitive salary, annual bonus and wider benefits package is on offer with this role. To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk
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