Regulatory Affairs Manager, CIS/Asia DC/Near East Cluster

Nome della sede: Warsaw, Egypt - Cairo, Poznan Data di apertura: Nov 29 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 organization 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 Affairs Manager, CIS/Asia DC/Near East Cluster manage Regulatory team and activities for the relevant markets within CIS/Asia DC/Near East Cluster in Emerging Market Partner organization to ensure access to medicines. This role is responsible for regulatory processes, continuity of supply and conformance to applicable Regulations, Regulatory standards and governance, including oversight and coordination of the operational matrix across Global Content Delivery, Regional Regulatory team and Regulatory Third (3rd) Party. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Management of marketing authorizations (MAs) and coordination of associated activities for assigned markets including the primary interface with Content Delivery and 3rd Party Service Provider to support regulatory submissions to local regulatory agencies Effective planning and tracking of regulatory activities for defined markets Ensures that GSK Labeling (PI/PIL) is compliant with MA and with regulatory requirements and available in local language as applicable. Co-ordinates the completion of local language translations by 3rd Party (as applicable) Ensures product information is compliant with MA and product pack changes are implemented in compliance with regulations and aligned to supply chain planning Co-ordinates all regulatory submissions and commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines Co-ordinates with Content Delivery the management of product registration documents and agency correspondence in regulatory databases and repositories Builds and maintains effective relationships with, and provide considered regulatory advice, leadership, and expertise to cross functional stakeholders Lead Resource management, objective setting, performance and development of staff, talent reviews and succession planning, through a coordinated, well managed, strategically aligned program Effective communication, collaboration, planning and oversight of Regulatory Third-Party service providers to achieve Regulatory objectives and meet compliance standards Participation and compliance in internal and external projects and activities. Ensure compliance against GSK’s Regulatory internal control framework: Monitor and keep abreast of changes in the regulatory environments. Provide intelligence to relevant stakeholders and central teams on potential impact changes in the regulatory environment in the region. Why you? Basic Qualifications: Master’s degree in Life Sciences / Pharmacy / professions aligned to medicine Fluent English language skills (speaking and writing) Min. 4 years of relevant experience in Regulatory Affairs People Management Experience Experience gained across multiple markets is preferred Experience of working effectively in a matrix across functions. Effective collaboration and negotiation with regulatory agencies. Work in complex regulatory environment. Well-developed and demonstrable skills working as a member of a multi-functional team Preferred Qualifications: Knowledge of the policies and regulatory climate in relevant Cluster within EM Partner Markets organization Experience of working with Regulatory Third Parties is preferable Ability to anticipate possible changes in the regulatory environment (relating to product development, NPI, and market access) proactively, to monitor their implementation, to assess and communicate possible risks and to prepare the mitigation strategy Ability to multitask and excel in cross-functional settings and to manage multiple issues in a fast-paced environment The ability to make decisions/influence outcomes that include assessment of the risk and impact on the business and using good judgment regarding when to refer issues to senior management Good listening and comprehension skills; ability to adapt personal style to a given audience; takes ownership and is productive in and has the courage to address potential problems before they become an issue Strong change management skills Why GSK? What we offer: Career at one of the leading global healthcare companies Contract of employment Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit) Life insurance and pension plan Private medical package with additional preventive healthcare services for employees and their eligible counterparts Sports card (Multisport) Possibilities of development within the role and company’s structure Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training) Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities) Supportive community and integration events Modern office with creative rooms, fresh fruits everyday Free car and bike parking, locker rooms and showers. *LI-GSK *LI-HYBRID Inclusion & Diversity at GSK: Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career. GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant. We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team ([email protected]) to further discuss this today. We will request equal opportunities information from you and whilst disclosure is optional, we encourage you to be open, enabling us to monitor the inclusivity of our recruitment practices for the benefit of everyone. Your data will remain confidential, is never shared with our Hiring Managers and never affects the status of your application. Se è necessaria accoglienza specifica o altro tipo di assistenza per presentare una domanda di lavoro presso GSK/ViiV Healthcare, contattare il centro servizi HR al numero 1-877-694-7547 (gratuito negli Stati Uniti) o al numero +1 801 567 5155 (fuori dagli Stati Uniti). GSK/ViiV è un datore di lavoro favorevole alle pari opportunità. Tutti i candidati qualificati riceveranno uguale considerazione per l'impiego a prescindere da razza, colore, nazionalità, religione, sesso, gravidanza, stato civile, orientamento sessuale, identità/espressione di genere, età, disabilità, informazioni genetiche, servizio militare, stato di veterano protetto stato o qualsiasi altra classe protetta federale, statale o locale. 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