Regulatory Specialist, Submission Coordination; Sde, Lcm

Regulatory Specialist Submission Coordination works closely with global submission teams Local Operating Company regulatory contacts to deliver end-to-end submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices This role offers an excellent opportunity to develop your expertise in Regulatory Affairs while collaborating with cross-functional teams and gaining exposure to global submission processes Basic Qualification - Responsible to deliver marketing applications and lifecycle maintenance submissions including activities such as product renewals site submissions variations within agreed timelines in compliance with Regulatory Authority regulations and guidelines GSK SOPs and working practices and in collaboration with relevant submission teams as needed Coordinate MSR for various types of submission independently and confidently executing agreed dossier strategy Assist in scenario planning when multiple regulatory strategies are considered Identify and escalate risks associated with submission delivery that have business impact Understand and apply regulations guidelines procedures and policies relating to the registration and manufacturing of pharmaceutical products to expedite submission delivery delivery Participating in process improvement initiatives as required Participate as needed in submission teams to support product regulatory authority submissions or maintenance activities for approved products including product renewals site registrations renewals variations and periodic benefit risk evaluation report PBRER submissions Mentoring training of other team members as required Why you Qualifications We are looking for professionals with these required skills to achieve our goals Degree in a biological healthcare or scientific discipline or Extensive experience in the Regulatory Affairs area Understanding of the pharmaceutical industry R D processes and objectives Ability to interpret regulations Ability to effectively interact with line and middle management staff and external contacts on a functional and strategic level in a matrix environment Ability to think flexibly in order to meet shifting priorities and timelines Good written and verbal communication skills and ability to present information in a clear and concise manner Good organizational skills attention to detail and commitment to deliver high quality output in a timely manner Ability to proactively identify and mitigate risks and potential bottlenecks apply sound judgement when determining if when to escalate issues and effectively interact with stakeholders to ensure transparency of submission progress status Ability to lead or co-lead multidisciplinary team meetings and facilitate discussions regarding submission content timelines resource allocation risk management etc 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