Junior Regulatory Specialist

Junior Regulatory Specialist supports, with appropriate guidance and oversight, operational activities related to maintenance of marketing authorisations (MAs) across assigned markets and/or submission types in European Partnership Markets, working in close collaboration with country leads, as well as global regulatory teams/centers and local 3rd party service providers, if applicable/directed.

Key Responsibilities:

• Supporting country leads in activities related to maintenance of marketing authorizations (MAs) for assigned markets and/or submission types across pharma and vaccines portfolio
• Supporting planning and tracking of regulatory activities for defined markets/submission types
• Managing, with appropriate oversight, routine operational steps within Regulatory Information Management (RIM) systems related to the local activities within end-to-end regulatory processes
• Supporting country leads with operational/system driven activities related to responses to regulatory questions and commitments
• Collaborating with global regulatory centers (GRC), if required, to support effective management of product registration documents and agency correspondence in RIM systems,
• Collaborating, with appropriate level of guidance, with global regulatory teams/centers to ensure compliance of regulatory documentation for different submission types with countries' requirements
• Supporting country leads with coordination of regulatory activities with external 3rd Party regulatory service providers
• Starts building and maintaining effective relationships with internal and external stakeholders.

Basic Qualifications:

• Basic knowledge of pharmaceutical industry, and regulatory processes related to license maintenance
• Experience gained through internship in pharmaceutical industry/company is of additional value
• Some level of experience in collaborating effectively in a matrix organization and/or international environment is preferrable
• Fluent Polish and English language skills (speaking and writing).

G10
 

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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.

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