Regulatory Affairs Executive/Manager

Site Name: Singapore - Rochester Park Posted Date: Feb 2 2023 Job Purpose The Regulatory Affairs Executive/Manager is required to support the business primarily in Singapore by leading the portfolio life cycle management, driving new registration filings and line extensions, managing regulatory activities and labelling updates for the products in the defined therapeutic areas in GSK. The Executive/Manager is also required to manage relevant regulatory initiatives and processes in line with local and corporate requirements. And provide regulatory advice to support the commercial activities including product launches and promotional materials review. Primary responsibilities Plan, strategize and monitor regulatory filings leading to timely submissions and approvals of new product registrations, line extensions and variation applications. Liaise with local regulatory authorities and Area/Global Regulatory to deliver timely and commercially advantageous license approvals. Respond to regulatory questions in a timely manner and following consultation with relevant stakeholders. Manage product life cycle maintenance e.g. changes in source, formulation, shelf life etc to ensure no impact to supply due to regulatory reason. Plan and submit labeling updates in line with central requirements and support pack changes and artwork development process to ensure compliance with local registered details and corporate prescribing information, as well as maximizing the commercial value of the label. Build effective working relationships with the regulatory agency i.e. HSA and follow up closely on approvals of product registration and variations. Work with all appropriate local functions to develop and implement the best regulatory plans to support commercial goals and product launch excellence. Ensure compliance with local, regional and Corporate regulatory SOPs and processes. Obtain all relevant licenses and import and export permits in compliance with regulatory requirements. Provide regulatory input to support promotional materials and activities in accordance with local regulatory and internal requirements. Support QMS and quality compliance activities including provision of regulatory input to the TTS, local repacking, change control, release of first shipment of new product to ensure compliance with the local registered details. Provide regulatory support to product incidents, recalls and audit activities where applicable. Why you? We are looking for professionals with these required skills to achieve our goals: Bachelor Degree in Pharmacy / Science Min. 3 years of local regulatory experience in pharmaceutical companies for Executive position, 6 years for Manager position Local registered pharmacist is highly preferred Good knowledge of current regulatory requirements. General pharmaceutical products knowledge. Professional written and verbal communication skills. Team work and people skills. Good time management skills, with ability to multi-task and work under pressure. Works with a spirit of continuous improvement and innovation Why GSK? To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. 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