Senior Regulatory Specialist GlaxoSmithKline

Senior Regulatory Specialist, CMC Renewals

Renewals CMC Team (Chemistry, Manufacturing, and Controls) 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.

Key Responsibilities:

• Independently manages multiple CMC (Chemistry, Manufacturing and Control) renewals assignments for Pharma and Vaccines products including response to questions from Agency; assignments will range in complexity but more complex work is expected;

• Independently and confidently defines and agrees on regulatory strategy, completes data assessment to ensure CMC dossier is authored in compliance with Company regulatory processes and external requirements for international markets;

• Identifies risks associated with submission data and information packages;

• Escalates issues with line manager that have business impact, suggesting possible solutions;

• Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications;

• Identifies improvement opportunities for regulatory processes, policies and systems;

• Serves as dossier reviewer (peer review and/or quality check);

• Provides consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff;

• Effectively communicates also in a digital context, including virtual meetings and digital platforms;

• Works with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time;

• Understands internal/external regulatory environment;

• Monitors regulatory intelligence and acts proactively on identified changes to regulatory requirements;

• Supports digital transformation through active participation in building digital skills.

Why You?

Basic qualifications:

• Min. bachelor's degree in Life Sciences, Chemistry, Health Sciences, or related fields;

• Min. 3 years of relevant experience in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation is required);

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

• Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner;

• Mindset that embraces digital transformation and innovation through adaptability, forward-thinking, and exploring new possibilities in the ever-evolving digital landscape;

• Good team worker, ready to lead initiatives when needed (project management skills would be an asset);

• Excellent interpersonal skills; communication and influencing skills with the ability to work in a diverse environment and build relationships across a large organization;

• Excellent time management skills to handle multiple assignments, prioritize and schedule work to meet business needs;

• Detail-oriented, with emphasis on accuracy, completeness and consistency;

• Agile and analytical thinking to independently provide solutions to issues or propose process/ways of working changes;

• Adaptability and Learning: A commitment to ongoing professional development with proven ability to learn and apply new concepts;

• Veeva Vault knowledge would be an asset.