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Global Regulatory Affairs Apprenticeship
4 weeks ago
Accountable to the GRL and Global Regulatory for the delivery of Marketing Application pre-approval investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices May be responsible for relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product including product renewals site registrations renewals variations label harmonisation periodic benefit risk evaluation reports PBRER submissions etc May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities May be the primary contact for the GRL maintaining the overall RMT workplan including relevant regulatory milestones according to the phase of development May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets May be required to process improvement initiatives Skills Why GSK Uniting science technology and talent to get ahead of disease together GSK is a global biopharma company with a special purpose - to unite science technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger more sustainable shareholder returns - as an organisation where people can thrive We prevent and treat disease with vaccines specialty and general medicines We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas infectious diseases HIV respiratory immunology and oncology Our success absolutely depends on our people While getting ahead of disease together is about our ambition for patients and shareholders it s also about making GSK a place where people can thrive We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be A place where they can be themselves - feeling welcome valued and included Where they can keep growing and look after their wellbeing So if you share our ambition join us at this exciting moment in our journey to get Ahead Together Important notice to Employment businesses Agencies GSK does not accept referrals from employment businesses and or employment agencies in respect of the vacancies posted on this site All employment businesses agencies are required to contact GSK s commercial and general procurement human resources department to obtain prior written authorization before referring any candidates to GSK The obtaining of prior written authorization is a condition precedent to any agreement verbal or written between the employment business agency and GSK In the absence of such written authorization being obtained any actions undertaken by the employment business agency shall be deemed to have been performed without the consent or contractual agreement of GSK GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses agencies in respect of the vacancies posted on this site It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way GlaxoSmithKline does not charge any fee whatsoever for recruitment process Please do not make payments to any individuals entities in connection with recruitment with any GlaxoSmithKline or GSK group company at any worldwide location Even if they claim that the money is refundable If you come across unsolicited email from email addresses not ending in gsk com or job advertisements which state that you should contact an email address that does not end in gsk com you should disregard the same and inform us by emailing askus gsk com so that we can confirm to you if the job is genuine
