Global Regulatory Compliance Specialist

7 dni temu

Poznań, Greater Poland GlaxoSmithKline Pełny etat

GSK's mission is to unite science, technology and talent to get ahead of disease together. As a Regulatory Affairs Manager, you will play a critical role in achieving this mission by ensuring that all regulatory processes are developed and implemented, ensuring continuity of supply and conformance to applicable Regulations, Regulatory standards and governance.

Job Description:

The Regulatory Affairs Manager will be responsible for leading the Regulatory team for Armenia, Belarus and Kazakhstan within the EM Partner Markets organization as well as providing support including oversight and coordination of the operational matrix across Content Delivery, Region and Regulatory Third (3rd) Party Partners.

Responsibilities:

  • 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 CRO (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;

  • 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;

  • Lead Resource management, objective setting, performance and development of staff, talent reviews and succession planning, through a coordinated, well managed, strategically aligned program;

  • 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.

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