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Regulatory Specialist (European Partnership Markets), Warsaw

Client:

Location: Warsaw, Poland

Job Category: Other

EU work permit required: Yes

Job Reference: c45e01540aff

Job Views: 22

Posted: 23.01.2025

Expiry Date: 09.03.2025

Job Description:

Regulatory Specialist supports 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.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

1. Supporting country leads in activities related to maintenance of marketing authorizations (MAs) for assigned markets and/or submission types across pharma and vaccines portfolio
2. Providing inputs and support to planning and tracking of regulatory activities for defined markets/submission types
3. Managing routine operational steps within Regulatory Information Management (RIM) systems related to the local activities within end-to-end regulatory processes, including data assessments
4. Supporting country leads with operational activities related to responses to regulatory questions and commitments; providing direct inputs depending on complexity and scope
5. Collaborating with global regulatory centers (GRC), if required, to support effective management of product registration documents and agency correspondence in RIM systems
6. Collaborating with global regulatory teams/centers to ensure compliance of regulatory documentation for different submission types with countries’ requirements
7. Supporting country leads with coordination of regulatory activities with external 3rd Party regulatory service providers
8. May be supporting country leads with activities related to timely trigger of products artwork updates
9. Building and maintaining effective relationships with internal and external stakeholders

Qualifications:

1. Master’s/ Bachelors degree (in scientific discipline (life sciences / pharmacy / professions aligned to medicine)
2. Approximately 2 years of relevant experience in regulatory affairs and pharmaceutical industry
3. Understanding of the pharmaceutical industry, and regulatory processes related to license maintenance
4. Awareness of the policies and regulatory climate in Europe.
5. Experience gained across various submission types (CMC and/or labelling) is preferable.
6. Experience of working effectively in a matrix organization and/or international environment is preferable
7. Fluent English language skills (speaking and writing)
8. Experience with Labelling will be an asset

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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