GSK

biopharma

RegistrationAssociate

Ukraine FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Entry candidates.

The Brief

“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.

biopharma
Problems you'll solve

Proactively escalate in case of risks, issues

Eligibility Requirements

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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