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Job Purpose
This role leads all CTA submission activities for new assets and pipeline products, ensuring timely and compliant regulatory submissions through effective stakeholder management and strategic planning to accelerate access to innovative therapies. While the primary focus of this role is CTA submission leadership, the position also provides support to regulatory compliance and Quality Risk Management (QRM) activities within LOC RA, with opportunities to collaborate on governance and continuous improvement initiatives.
This role reports to directly to RA Head, but not a people manager.
Key Responsibilities
Regulatory Submission Management (CTA Expertise)
Lead planning and execution of Clinical Trial Application (CTA) submissions in close collaboration with Clinical Operations and cross-functional stakeholders.
Oversee CTA submission timelines and ensure timely, high-quality, and compliant submissions to the Health Authority.
Review and approve CTA submission packages prepared by RA team members to ensure regulatory compliance and submission readiness.
Independently prepare and manage CTA submissions for designated new assets or priority development programs, as required.
Serve as the Local Subject Matter Expert (SME) for CTA regulations and submission processes, providing regulatory guidance and coaching to RA colleagues.
Support effective interactions with the MFDS throughout CTA review and approval processes.
Monitor changes in local clinical trial regulations, guidelines, and regulatory policies; assess potential impacts and communicate relevant updates to local, regional, and global stakeholders.
Contribute to regulatory intelligence activities by providing strategic insights on emerging regulatory trends and requirements.
Participate in external advocacy and policy-shaping initiatives with regulatory authorities, industry associations, and relevant stakeholders, as appropriate.
Drive continuous improvement of CTA submission processes and regulatory operational excellence.
Support for Regulatory Compliance and QRM activities (as back-up, scope to be aligned)
Support regulatory compliance monitoring activities and contribute to KPI tracking and reporting.
Contribute to the implementation and continuous improvement of the QRM framework within LOC RA.
Assist in identifying and assessing regulatory and quality risks in collaboration with relevant stakeholders.
Support deviation, RCA, and CAPA management activities as part of broader compliance processes.
Contribute to inspection and audit readiness activities.
Collaborate with local and global stakeholders to support alignment on compliance and quality requirements.
Requirements
Minimum 9 years of experience in Regulatory Affairs, with substantial expertise in CTA submissions and a solid understanding of Regulatory Compliance, QMS, and/or QRM is desirable.
Required to manage CTA submissions and to manage compliance systems, interpret audit findings, and drive CAPA effectiveness
Bachelor’s degree (Life Science/Pharmacy)
Strong knowledge of local and global CTA regulations and guidelines, with hands-on experience in preparing, reviewing, and submitting CTAs to the Ministry of Food and Drug Safety (MFDS).
Strong knowledge of QMS, CAPA, risk management
Audit and inspection readiness experience
Good understanding of regulatory requirements and product lifecycle management
Strong stakeholder management, cross-functional collaboration, and effective communication skills to engage with Health Authorities and global/regional stakeholders
*LI-GSK
Skills
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.
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