As a Regulatory Compliance Officer, you will ensure corporate compliance by providing accurate interpretation of Group standards, pharmacopeial requirements, and commitments made to regulatory authorities. You will support site readiness for inspections from internal and external authorities and ensure products are manufactured and supplied in compliance with all licensing requirements. You will also contribute to the development of regulatory strategies, manage product registration, and facilitate regulatory approval without undue restrictions on company operations.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Contribute to the development of regulatory strategies and manage the registration of new products to facilitate regulatory approval without undue restrictions on company operations.
Manage and deliver regulatory filings and maintenance activities to meet Singapore regulatory requirements and timelines.
Maintain submission trackers, dossier version control and records to keep audit-ready documentation.
Prepare timely responses to regulator questions and support meetings with authorities as needed.
Monitor and report compliance metrics, identify gaps, and drive improvements for regulatory processes.
Support site change control, investigations, and batch release, acting as an initiator or enabler for change implementation.
Conduct expert reviews of information, facilities, and practices to ensure compliance with standards and implementation of required regulatory strategies.
Maintain site inspection readiness through establishment of site GEMBA, audit risk identification, and effective mitigation.
Maintain site validation status by performing periodic product reviews and reviewing/approving periodic validation reports.
Support product incident, recall and quality-related regulatory activities as required.
Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
At least an honours degree in a relevant science discipline.
Minimum 5 to 8 years of relevant experience in the pharmaceutical industry for Senior Regulatory Compliance Officer and at least 2 years of relevant experience for Regulatory Compliance Officer.
Practical experience with product registration, variations and licence maintenance.
Experience managing labelling and packaging changes.
Good written and verbal communication skills in English.
Extensive knowledge in GMP, quality, and manufacturing processes.
Good audit skills and technical writing skills.
Strong internal and external communication skills.
Good investigating skills.
Strong organisational skills with attention to detail and the ability to manage multiple priorities.
Preferred Qualification
If you have the following characteristics, it would be a plus:
Registered pharmacist in Singapore or equivalent local professional registration.
Experience working with local health authority procedures and timelines.
Experience with site inspection readiness and audit management processes.
Familiarity with quality systems and change control processes.
Familiarity with regulatory intelligence and compliance requirements.
Experience with electronic submission formats or regulatory information systems.
Experience working in a matrixed environment with global and local stakeholders.
Ability to analyse and provide recommendations for gap closure.
Demonstrated ability to influence stakeholders and drive process improvements.
Demonstrated ability to implement regulatory strategies effectively.
To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore
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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.
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