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The Regulatory Submission Specialist, Submission Delivery Excellence (SDE), Lifecycle Management (LCM) works closely with global submission teams and Local Operating Company (LOC) regulatory contacts to deliver end‑to‑end regulatory submissions in line with agreed timelines. This includes the coordination and preparation of LOC Market‑Specific Requirements (MSRs), including MSRs developed and maintained in Spanish, in compliance with Regulatory Authority regulations and guidelines, and in accordance with GSK ways of working. This role offers an excellent opportunity to further develop expertise in Regulatory Affairs while collaborating with cross‑functional teams and gaining exposure to global submission and lifecycle management activities.
Job Responsibility:
Lead end-to-end delivery of marketing applications and lifecycle maintenance submissions (renewals, variations, site registrations) in compliance with Regulatory Authority requirements, internal SOPs, and agreed timelines
Coordinate, author, and review Local Operating Company (LOC) Market-Specific Requirements (MSRs) — including documentation in Spanish — ensuring alignment with global dossier strategy and local regulatory expectations
Execute and support regulatory submission strategies across multiple scenarios, independently managing dossier planning, documentation readiness, and cross-functional inputs
Identify, assess, and proactively escalate submission-related risks with potential business impact, implementing mitigation plans to protect timelines and approvals
Apply regulatory guidelines, policies, and pharmaceutical manufacturing/registration requirements to ensure high-quality, compliant submissions
Lead or co-lead multidisciplinary discussions related to submission content, resource planning, timelines, lifecycle management, and continuous process improvement initiatives.
Requirements:
Degree in a biological, healthcare, or scientific discipline (or equivalent experience in Regulatory Affairs)
Solid understanding of pharmaceutical development, R&D processes, product registration, and lifecycle management
Proven ability to interpret and apply regulatory frameworks and translate requirements into compliant submission strategies
Fluency in Spanish (written and spoken) with experience preparing and reviewing regulatory documentation and MSRs in Spanish
strong professional communication skills in English
Experience working in global, matrix environments, effectively engaging cross-functional teams and management levels
Strong organizational skills, attention to detail, risk-based thinking, and ability to manage shifting priorities while delivering high-quality outputs on time.