Senior Regulatory Specialist (CMC) – GSK

As a Senior Regulatory Specialist, you have the unique opportunity to join GlaxoSmithKline (GSK), a world-leading biopharma company, and build a career with real-world purpose. On behalf of GSK, we are looking for a highly qualified professional to fill the role of Senior Regulatory Specialist, specializing in New Registration CMC (Chemistry, Manufacturing, and Controls) Excellence.

Role Overview

The Senior Regulatory Specialist is responsible for the timely delivery of regulatory activities across multiple projects and diverse dosage forms. In this position, you will represent the New Registration CMC team on global regulatory networks and internal matrix teams. Your strategic guidance will directly support Global Supply Chain (GSC), Commercial, Quality Assurance, 3rd Party Contract Management (via ESQ), and the Office of the Chief Medical Officer (OCMO) to produce pristine, fully compliant global regulatory dossiers.

Key Responsibilities

1. Dossier Strategy Execution: Independently and confidently execute agreed dossier strategies for new asset registrations.

2. Project Management: Simultaneously manage multiple complex projects ranging in technical difficulty across global sites.

3. Data Assessment: Conduct critical data evaluations to guarantee that all submission packages are optimized and fit for purpose.

4. Risk Management: Identify potential technical or timeline risks associated with submission data and proactively escalate business-impacting issues to line management.

5. Peer Review & Process Improvement: Serve as a key dossier reviewer for peers while identifying process optimization opportunities within internal regulatory policies and systems.

6. Compliance & Regulations: Maintain an extensive understanding of international regulations, manufacturing policies, and pharmaceutical guidelines to expedite global submissions. Candidates are encouraged to reference the latest FDA Regulatory Guidelines and international frameworks to stay aligned with changing criteria.

7. Mentorship: Act as a dedicated mentor and trainer for onboarding staff members to build technical capabilities within the CMC department.

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Qualifications

1. Education: Bachelor’s degree in Chemistry, Pharmacy, a technical discipline, or an equivalent biological science.

2. Language Skills: Professional-level fluency in English (both written and verbal communication).

3. Industry Knowledge: Proven understanding of global drug development, pharmaceutical manufacturing processes, and supply chain logistics.

4. CMC Domain Expertise: Solid foundational knowledge of worldwide CMC post-approval or new registration regulatory requirements.

5. Core Competencies: Superior learning agility, digital fluency, problem-solving capabilities, and the capacity for influencing without authority across matrix teams.