Chemical Regulatory Affairs Job at GSK | Apply Now
Are you looking for a Chemical Regulatory Affairs Job in a global pharmaceutical company? GSK Careers has opened an exciting opportunity for a Senior Regulatory Specialist – CMC Renewals role. This opportunity is ideal for candidates with backgrounds in Life Sciences or Chemistry, including those seeking a BSc Chemistry Job in regulatory affairs. Join one of the world’s leading biopharma companies and work on regulatory submissions that ensure pharmaceutical and vaccine products remain safe, effective, and compliant for patients worldwide.
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can
thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact, and doing the right thing is the foundation for how, together, we deliver for patients, shareholders, and our people.Job Title: Senior Regulatory Specialist, CMC Renewals
- Locations: Poznan Grunwaldzka, Poland; Bengaluru, India; Cairo, Egypt; Warsaw, Poland
- Department: Regulatory
- Job ID: 436496
- Site Name: Poznan Grunwaldzka, Bengaluru Luxor North Tower, Egypt – Cairo, Warsaw Rzymowskiego 53
Job Description:
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. The 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 the 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 the line manager that have a 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 as a subject matter expert in specific areas. 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 a 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 by actively 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.
Why GSK?
Uniting science, technology, and talent to get ahead of disease together.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service, or any basis prohibited under federal, state, or local law.
If you are searching for a Chemical Regulatory Affairs Job, exploring GSK Careers, or aiming to start a BSc Chemistry Job in the pharmaceutical regulatory field, this opportunity provides a strong platform to build a global career in regulatory science.
