Informacje o stanowisku

Site Name: Poznan Grunwaldzka, Warsaw

Posted Date: Dec 9 2024

Regulatory Specialist with digital experience (Renewals)

What we are doing?

Global Regulatory Centres (GRC) in GSK are regulatory affairs functions which bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, licence maintenance and lifecycle management dossiers, and regulatory information management. The Global Regulatory Centres provide regulatory support across the product lifecycle for pharmaceutical, biopharm and vaccines products (clinical development to market maturity).

Renewals CMC Team (Chemistry, Manufacturing, and Controls) is part of GRC and plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use. Team is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. While the science is our main area we are also working with technology to perform at our best as we operate in a fast-paced and evolving environment.

Your Responsibilities:

• Supporting digital transformation through active participation in building digital skills
• Evaluating and implementing innovative solutions for CMC Regulatory processes, policies and systems
• Managing multiple CMC (Chemistry, Manufacturing and Control) renewals assignments for Pharma and Vaccines products including response to questions from Agency
• Define and agree regulatory strategy, complete data assessment to ensure CMC dossier authored in compliance with Company regulatory processes and external requirements for international markets
• Effective communication also in a digital context, including virtual meetings and digital platforms
• Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time
• Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements
• Act as subject matter expert in regulatory processes

Why you?

We are looking for professionals with these required skills to achieve

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