Registration Executive, Regulatory Affairs Department (Maternity Leave position for 12 months)

The Regulatory Affairs team ensures compliance, efficient registration, and license to operate of pharmaceutical products, vaccines in Ukraine, supporting company operations and quality standards.

The Registration Executive manages regulatory processes for product registration, renewals, and variations, while ensuring compliance with regulations and GSK standards. The role involves collaboration with internal teams and regulatory institutions to support product registration and support maintenance of the Quality Management System (QMS).
 

Key Responsibilities:

Prepare, submit, update, and manage registration dossiers for pharmaceutical products and vaccines.Handle of post-registration activities such as variations, and renewals for pharmaceutical products and vaccinesCollaborate with logistics and supply teams to coordinate registration activities timelinesEstablish and maintain relationships with regulatory institutions; handle pre-registration analyses.Ensure proper archiving, document updates, and compliance with GSK and local standards.Prepare and submit documentation for GMP compliance confirmation in Ukraine.Timely update of the internal regulatory systems in accordance with GSK standards and requirements

Basic Qualifications:

University degree (Master/Magister preferred).At least 1 year of experience in a related field.Fluency in English, both written and oral.Strong communication skills.Knowledge of Ukrainian legislation on registration/re-registration of medicinal products and GMP compliance.

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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.

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.

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