Candidates

Job title: Global Regulatory Affairs Director, Paediatrics A well-known pharmaceutical company are seeking a Global Regulatory Affairs Director to work in their recently launched paediatric centre of excellent office in Dublin. This is an exciting opportunity to join HIV and Emerging Viruses Regulatory Affairs where you will provide global regulatory strategic and technical leadership of regulatory activities for pediatric product development. Responsibilities: Responsible for providing strategic regulatory guidance on the development of global pediatric submissions, including those required in the US and EU. Responsible for leading all pediatric-related regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidance for pediatric products is met for assigned product(s) and territories. Maintains knowledge of highly complex regulatory requirements up to date, contribute to preparation of new pediatric regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management. Prepare and/or manage others' submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs. Requirements: Significant level of experience in Regulatory Affairs or other relevant industry experience with advanced degree Must have extensive knowledge of pediatric regulatory requirements, including ICH requirements and regional requirements for assigned territories and an understanding of current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business. Degree in a scientific field is preferred Pediatric drug development experience is required Is recognized as an expert resource for Regulatory Advice in other departments. Salary and benefits: A highly competitive annual salary, car allowance, bonus, initial stock reward, annual stock reward, private medical and pension are on offer. A generous relocation package is also available - offering temporary accommodation, home sale assistance and rent contribution. 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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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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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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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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