job title: Senior regulatory specialist (GSK)

Roles and Responsibilities

Key Responsibilities include, but are not limited to:

• Managing multiple project assignments simultaneously, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Pharma products (working with the CTD Module 3, Quality section of the dossiers).

• Managing assigned projects by executing agreed dossier strategies, completing data assessments to ensure dossiers are fit for purpose and in compliance with GSK regulatory processes and external requirements for local markets (e.g., Europe, US, and International countries), and identifying risks associated with submission data and information packages.

• Preparing and coordinating the review and approval of submission-ready documents.

• Collaborating with Product Owners/Project Managers to provide regulatory support for assigned projects.

• Working with colleagues in the Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies in markets worldwide to deliver high-quality dossiers on time.

• Building and maintaining strong relationships with internal and external stakeholders.

• Monitoring regulatory intelligence and proactively acting on identified changes to regulatory requirements.

• Identifying improvement opportunities for CMC regulatory processes, policies, and systems.

Basic qualifications:

• Bachelor’s or Master’s degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.

• Relevant experience in regulatory affairs (the pharmaceutical industry), with familiarity in post-approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).

• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.

• Thorough understanding of change management processes and regulatory requirements.

• Attention to detail with an emphasis on accuracy and completeness.

• Ability to handle multiple tasks, meet shifting priorities, and schedule work to meet business needs.

• Flexible and analytical thinking to independently provide solutions to issues.

• Excellent interpersonal skills, including the ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization.

• Excellent written and verbal communication skills in English.