Regulatory Affairs Job at GSK | BSc Chemistry Graduates Apply Now
Looking for a Regulatory Affairs Job in the pharmaceutical industry? This opening under GSK Careers is an exciting opportunity for professionals seeking BSc Chemistry jobs, chemistry jobs, and advanced pharma jobs. The role of Senior Regulatory Specialist focuses on CMC renewals and global regulatory submissions, making it ideal for candidates aiming to grow in regulatory and compliance domains.
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.
GSK is a leading global biopharmaceutical company focused on uniting science, technology, and talent to get ahead of disease together. Through GSK Careers, professionals gain opportunities to work on impactful healthcare solutions and contribute to improving the lives of millions worldwide.
- Job Post: Senior Regulatory Specialist, CMC Renewals
- Location: Poznan Grunwaldzka, Poland; Bengaluru, India; Cairo, Egypt; Warsaw, Poland
- Category: Regulatory
- Job ID: 436496
Site Name: Poznan Grunwaldzka, Bengaluru Luxor North Tower, Egypt – Cairo, Warsaw Rzymowskiego 53
Job Role
The Senior Regulatory Specialist role is part of the CMC (Chemistry, Manufacturing, and Controls) renewals team. This regulatory affairs job involves managing global regulatory submissions, ensuring compliance with international guidelines, and supporting pharmaceutical product approvals. This GSK careers opportunity is ideal for candidates with experience in pharma jobs, regulatory processes, and a background in BSc Chemistry jobs or life sciences.
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 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 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 through active participation in building digital skills.
Requirements
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.
This role under GSK Careers is an exciting opportunity for professionals seeking a Regulatory Affairs Job in the global pharma industry. If you are looking to grow in BSc Chemistry jobs and regulatory roles, this position offers excellent career advancement and global exposure.
