Chemistry Regulatory Affairs Job at GSK | Candidates Apply Now
Are you looking for a Chemistry Regulatory Affairs Job in a globally recognized pharmaceutical company? Explore exciting GSK careers with this BSc Chemistry Job opportunity as a Regulatory Specialist. This role offers a dynamic environment where science meets compliance, giving you the chance to work on global regulatory submissions and contribute to delivering safe and effective medicines worldwide.
About GSK:
GSK is a leading global biopharmaceutical company focused on improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong presence in pharmaceuticals, vaccines, and consumer healthcare, GSK offers excellent career opportunities in Chemistry Regulatory Affairs Jobs and supports innovation, diversity, and professional growth across global teams.
Regulatory Specialist – Chemistry Regulatory Affairs Job | GSK Careers | BSc Chemistry Job
- Location: Poznan Grunwaldzka, Poland; Bengaluru, India; Cairo, Egypt; Warsaw, Poland
- Job ID: 437431
- Category: Regulatory
Job Description:
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. The team is responsible for authoring, compiling, and checking regulatory submissions
related to drug manufacturing and quality control. While 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 (Chemistry Regulatory Affairs Job):
- Manages multiple CMC (Chemistry, Manufacturing and Control) renewals assignments for Pharma and Vaccines products, including response to questions from the Agency.
- 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.
- 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.
Qualifications (BSc Chemistry Job Requirements):
Basic qualifications:
- Min. bachelor’s degree in Life Sciences, Chemistry, Health Sciences, or related fields.
- 1-2 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.
- 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.
What We Offer (GSK Careers Benefits):
- Performance with Choice – flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours.
- Established job in an international, well-known pharmaceutical company.
- Opportunity to work in a professional team plays a crucial role in maintaining the GSK portfolio in the markets.
- Opportunity to work within GSK standards and documentation applied globally.
- Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus).
- Supportive & friendly working environment.
