Regulatory Manager, CTA/IND

Nome della sede: Poznan Grunwaldzka, Warsaw Data di apertura: Nov 27 2022 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Find out more: Annual Report 2021 Regulatory Manager, CTA/IND This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: manage people aspects of a team of direct reports to create and sustain an efficient and motivating working environment, manage and take accountability of workload within assigned team and work with functional lead to address resource challenges, support coordination, development, refinement of the CTA/IND (Clinical Trial Authorization/ Investigational New Drug) lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures. identify risks to quality and/or timely completion of project, resolving any issues and escalating items to be resolved at a higher management level, drive continuous process improvement within areas of your influence, monitor regulatory intelligence and act proactively on identified changes to regulatory requirements, take accountability for tracking, analyzing and reporting of team performance against departmental KPIs. build and maintain quality relations with your internal and external stakeholders, work closely with your peers and CTA/IND Head to drive standardization across the business. Work with staff from other functions and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidance’s, researching topics and resolving issues. Why you? Basic Qualifications: Relevant experience in Regulatory Affairs in the R&D, pharmaceutical industry or clinical trials Master's degree in biotechnology, pharmacy, chemistry or other related science or technical field Capability to build, motivate and maintain a team Fluent English (verbal and written) Strong interpersonal and communication skills Adapting to changing circumstances through priorities reassessment and a disciplined, logical work style Direct or indirect experience of regulatory processes associated with gaining and maintaining product registrations for both Investigational and Licensed Products Proficient knowledge of Clinical Trial Directive, DIA TMF Reference Model and CTA/IND submission requirements for multiple countries/submission types Sound understanding of the pharmaceutical industry and regulatory processes Preferred Qualifications: Well-developed and proven leadership skills Negotiation and problem solving skills Knowledge of practical implementation of the European Clinical Trial Directive (EU CTR) Knowledge of Investigational New Drug (IND) applications Project Management experience Adapting to changing circumstances through priorities reassessment and a disciplined, logical work style Veeva Vault knowledge would be an asset Why GSK? We offer: Important, established and interesting job in one of the leading global healthcare companies. Possibility to work with engaged and enthusiastic people from various locations. Opportunity to work in a professional team, playing crucial role in supporting GSK portfolio worldwide Access to newest technologies and solutions. Possibilities of development within the role and company’s structure. Attractive reward package (annual bonus, awards for outstanding performance, rewards and recognition programme, private medical healthcare, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance). Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training). Extensive support of work life balance (flexible working solutions, remote work, short Fridays option, health & well-being activities). Supportive community and integration events.
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