Regulatory Specialist

Website GSK GSK

Role Information

As a Regulatory Specialist at GSK, you will work within the Renewals CMC Team. This team plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use. You will be responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control.

In this position, the Regulatory Specialist defines and agrees on regulatory strategy, completes data assessment to ensure CMC dossiers are authored in compliance with company processes and external requirements for international markets. You will identify risks associated with submission data and information packages, escalating issues with line managers that have business impact while suggesting proactive solutions.

Key Responsibilities for the Regulatory Specialist

The daily life of a Regulatory Specialist at GSK involves a blend of scientific analysis, strategic planning, and digital collaboration. Your core duties include:

  1. Submission Management: Managing multiple CMC renewal assignments for Pharma and Vaccines products, including responding to questions from global Health Agencies.

  2. Compliance & Strategy: Ensuring all authored dossiers meet the rigorous standards set by the International Council for Harmonisation (ICH) for CTD documentation.

  3. Digital Transformation: Utilizing advanced platforms like Veeva Vault to manage documentation and support GSK’s move toward a fully digital regulatory environment.

  4. Stakeholder Collaboration: Working with colleagues in Global Manufacturing & Supply (GMS) and GSK Local Operating Companies (LOCs) worldwide to deliver high-quality dossiers on time.

  5. Market Intelligence: Monitoring the internal and external regulatory environment to act proactively on changes to global requirements.

Qualifications and Skills:

  1. A Bachelor’s degree in Life Sciences, Chemistry, Health Sciences, or a related field.

  2. 1-2 years of relevant experience in regulatory affairs within the pharmaceutical industry.

  3. Familiarity with post-approval CMC regulatory procedures.

  4. Excellent written and verbal English communication skills.

  5. An agile mindset that embraces innovation and digital transformation.

To apply for this job please visit jobs.gsk.com.