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 Associate 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:
-Ensure support in preparation, update and completion of registration dossier according to local requirements in order to obtain new registration, renewals and variations for pharmaceutical products, vaccines.
- Proactively escalate in case of risks, issues.
-To conduct verification checking of ANDs, PILs in accordance with registration materials prepared for submission to the Regulatory Authority, or/ and in accordance with approved reg. documents.
- Ensure support in coordination of registration questions as well as labeling and GMP compliance.
- Upon receiving requests/comments from local regulatory authorities, ensure proper archiving of them
- Maintain appropriate level of archiving and usage of documents in compliance with Company’s and local requirements. To archive registration dossiers and communications with RA databases
-Support the payment process for registration procedures in accordance with the company's requirements and timelines. Monitor the status of payments for registration procedures. Prepare and archive payment documents in compliance with company requirements. Regularly update the payment registry.
Basic Qualifications:
-University Degree level qualification required
-Master/ Bachelor.
-1+ year of experience
-Intermediate English, oral and written.
-Good communication skills
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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.
Contact information:
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