GSK
biopharma
RegistrationAssociate
Neural analysis suggests this role is
optimal for Entry candidates.
“Registration Associate at GSK. Skills: product registration, renewals, variations, compliance with regulations, Quality Management System (QMS) maintenance. manages regulatory processes for product registration, renewals, and variations. ensuring compliance with regulations and GSK standards”
Industry & Context.
Proactively escalate in case of risks, issues
Maternity Leave position for 12 months
What They're Looking For.
Must Have
University Degree level qualification required, 1+ year of experience, Intermediate English, oral and written, Good communication skills
What You'll Do.
manages regulatory processes for product registration
ensuring compliance with regulations and GSK standards
support maintenance of the Quality Management System (QMS)
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
Proactively escalate in case of risks
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
How You'll Work.
Team & Collaboration
collaboration with internal teams and regulatory institutions
Communication Scope
Good communication skills; Intermediate English, oral and written
Full Job Description
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 G9 #LI-GSK **Why GSK? Uniting science, technology and talent to g
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