Regulatory Submissions Specialist

Regulatory Submissions Specialist Sandwich £18.00 - £25.00 Per Hour Our client, a global pharmaceutical company based in Sandwich, is currently looking to recruit a Regulatory Submissions Specialist to join their growing team on a 1-year contract. This role will help to manage pre-publishing and submission ready activities for MGRG Respiratory and Biologics Portfolio across the major markets (US, EU, CA, AUS, Japan and China). Duties Support to the authors both internal to our client and external (3rd party Vendors) on pre-publishing and submission readiness activities Support to the Global Regulatory Leads in delivering various types of submissions Collaborate with the Publishing Teams globally in providing published output for the various types of submissions, including ANDA's, BLA's, MAA's and IND's across the major markets Manage the pre-publishing/submission readiness activities for various types of submissions Apply detailed knowledge and understanding of the major markets' submission requirements Attend team meetings to give input into timelines for the submission build and submission ready requirements Support the dossier authors on the regional submission ready requirements Liaise with global and regional functional lines, and 3rd party Vendors in order to ensure that our clients' document standard is represented Personal Specification Demonstrated submission publishing/regulatory experience Proficient in Adobe Acrobat (with plug-ins), MS Excel and MS Word Detailed knowledge of document management systems such as Documentum Demonstrated project management, interpersonal and leadership skills Knowledge of US and European pharmaceutical regulations and guidelines as they pertain to regulatory submissions/publishing requirements Understanding and practical experience of submission readiness/publishing tools for MAA's, CTAs NDA's, ANDA's, BLA's and IND's in eCTD format If you would like to discuss this position in further detail please call Nicole on freephone or email About Morgan Jones: Morgan Jones Recruitment Consultants Limited acts as an employment agency for permanent recruitment and as an employment business for the supply of temporary workers. By applying for this job, you accept the Terms & Conditions, Privacy Policy and Data Protection and Information Security Policy which can be found on the Morgan Jones website. Due to the high volume of applicants applying for all roles, we can only reply to candidates with the most relevant skills and experience. If you have not heard back from us within 48 hours of your application, please assume that you have been unsuccessful on this occasion. To view other great opportunities, visit our website or follow Morgan Jones on your favourite social networks - Facebook, Twitter or LinkedIn.