3 Days Left: Senior Associate

Basic Qualifications 7 - 10 Years of relevant experience in regulatory Independently use judgement strict adherence to GSK and IRM plan quality and process expectations industry and regulatory standards and drug development experience to deliver high quality integrated Regulatory Development Plans RDPs based on input from GRLs and project teams on the overall development strategies associated with projects asset by indication Responsible for maintaining integrated Regulatory Development Plan RDP for operationalizing the Global Regulatory Strategy as defined by the GRL ensuring regulatory deliverables timelines and resource needs are accurately captured for each phase of development Provide Regulatory functional line planning support at the project level will support multiple projects under one Asset if applicable from Commit to Candidate C2C e post-approval R D activities Manage work packages add delete move as appropriate within the RDP to ensure the necessary Regulatory deliverables and agreed Global Reg Strategy are reflected Must understand the importance of RDPs reflecting accurate development strategies through the management of these work packages and associate logic and touchpoints with other plan types Review and manipulate as needed the predecessor successor logic within the RDP create scenarios and communicate what is driving Regulatory deliverable dates to the team and other PMs working on the project Perform scenario planning through developing alternative planning schedules for development team and portfolio decision making Proactively partner with other functional plan owners project managers from Medical Safety Clinical etc to ensure awareness of regulatory deliverables and alignment across all plan types within a project group Support R D Governance reviews e g Development Review Board DRB and Portfolio Investment Board PIB at key stage gates in the development process e g C2P2 C2P3 C2F L as well as Dynamic Portfolio Review dPR - facilitate RMT and broader Regulatory review of resource forecasts both external and internal project expenses - EPE IPE and FTE Ensure any requested data is complete accurate and fit for purpose for informing business decisions With support from line managers RPMs as needed build the associated schedules to drive Regulatory resource forecast estimates forecast cost EPE and resource FTE IPE associated with integrated plans Partner with key stakeholders including PMMT members and functional Project Managers etc to ensure plan schedule alignment to intended strategy Preferred Qualifications Broad understanding of the pharmaceutical industry drug development environment and R D processes and objectives Project management experience preferably in the pharmaceutical industry or in a regulatory environment Ideally possessing knowledge of Regulatory Affairs responsibilities from pre-IND through post-approval Experience with project management principles and systems e g Planisware resource management and reporting features e g Spotfire Ability to work well both independently and within a matrix environment to ensure on-time delivery of objectives Strong project management skills and ability to work with stakeholders spanning multiple functional areas Excellent written and verbal communication skills and ability to present information in a clear and concise manner Must be able to work with minimal supervision in a complex organization contributing to the successful delivery of departmental objectives Must have project management and prioritization skills to enable successful delivery of projects and initiatives Ideally familiar with the overall concept of resource management and algorithmically driven resource forecast Ability to contribute to the assessment and interpretation of Regulatory resource needs in collaboration with functional line project managers and SMEs Why GSK Uniting science technology and talent to get ahead of disease together GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together We aim to positively impact the health of 2 5 billion people by the end of the decade as a successful growing company where people can thrive We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines We focus on four therapeutic areas respiratory immunology and inflammation oncology HIV and infectious diseases - to impact health at scale People and patients around the world count on the medicines and vaccines we make so we re committed to creating an environment where our people can thrive and focus on what matters most Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people Inclusion at GSK As an employer committed to Inclusion we encourage you to reach out if you need any adjustments during the recruitment process Please contact our Recruitment Team at IN recruitment-adjustments gsk com to discuss your needs 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