Senior Specialist (Biopharma)

Roles & Responsibilities:

• Coordinate end-to-end regulatory lifecycle activities for mature biopharmaceutical products, including CMC variations, Health Authority queries, and post-approval commitments
• Manage assigned regulatory delivery projects, ensuring dossiers are compliant, complete, and submitted on time across multiple global markets
• Assess submission data, identify risks, drive issue resolution with stakeholders, and escalate where required to protect compliance and timelines
• Collaborate closely with CMC Regulatory Strategy, Supply Chain, Quality, IT teams, and external partners
• Maintain regulatory records, support submission systems administration, user training, and testing activities
• Monitor regulatory intelligence and proactively respond to changes in global regulatory requirements
• Mentor colleagues, share best practices, and contribute to cross-functional process improvement initiatives

Qualification:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, or a related technical discipline

Experience:

• Minimum 5 years of experience in regulatory operations, regulatory affairs, or submission delivery within the pharmaceutical or biopharma industry
• Hands-on experience with post-approval CMC regulatory activities and ICH CTD documentation (Modules 2 & 3)

Skills:

• Strong understanding of regulatory processes, change management, and lifecycle maintenance
• Experience with dossier management, document control, and regulatory systems (e.g., SharePoint)
• Excellent analytical, organizational, and problem-solving skills
• Ability to manage multiple priorities and meet deadlines in a global environment
• Strong written and verbal communication skills in English
• Proven ability to work collaboratively across cross-functional and international teams

About the Organization:

GlaxoSmithKline (GSK) is a leading global biopharmaceutical company dedicated to uniting science, technology, and talent to get ahead of disease together. With a strong global presence and a diverse portfolio spanning vaccines and medicines, GSK offers professionals meaningful work, global exposure, and opportunities to grow while making a positive impact on patient health worldwide.