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: Senior Publishing Associate - eCTD Submissions A pharmaceutical business in North London are seeking an experience regulatory affairs individual with extensive eCTD submissions experience. This role will support UK and EU teams by publishing and dispatching eCTD (CTD) submissions. Responsibilities: Build, dispatch and archive eCTD (CTD) major (initial) and lifecycle management submissions, ensuring that all final electronic deliverables meet current regulatory electronic document requirements and guidance Develop and maintain working knowledge of internal and external publishing standards Archive published dossiers and administrative data on appropriate file-shares Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions Develop, implement and QC review of submission standards. Participate in Global Regulatory Affairs project teams Requirements: Proficiency in publishing regulatory submissions and using regulatory e-submission software Minimum 2 years' experience in the Pharmaceutical Industry Knowledge and understanding of EU and ICH publishing regulations and guidelines Proficiency in publishing regulatory submissions and using regulatory e-submission software 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: Head of Regulatory Affairs A Pharmaceutical business in London are looking for a Head of Regulatory Affairs to join their Global team. This role is focused on leading a team to help support new product submissions and authorisations leading to a successful launch into global markets. Responsibilities: Provide strategic advice to the team and other stakeholders at an early stage of product development. Approve Regulatory Strategies for any new submissions as well as identifying risks. Maintain project timelines for all regulatory activities leading to the overall launch of the product on time. Have a hands-on approach to running procedures and if necessary be able to run projects independently. Requirements: Substantial experience within Regulatory affairs and Pharmaceutical industry. Significant experience managing submissions within EU markets. Have an excellent knowledge of various competent authorities for scientific advice or pre-submission meetings. Have a flexible management style and be able to have a hands-on approach when needed. Salary and benefits: A highly competitive salary and wider benefits scheme is on offer To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk

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