Regulatory Affairs Manager
GLAXOSMITHKLINE PTE LTD
Healthcare / Pharmaceutical
S$5000 - S$9500
- The Regulatory Affairs Executive/Manager is required to support the business primarily in Singapore by leading and driving new registration filings and line extensions, maintaining product life cycle, managing regulatory activities for 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.
- 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
- 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.
- About 6 years’ local regulatory experience in pharmaceuticals MNC for Manager
- Good knowledge of current regulatory requirements.
- General pharmaceutical products knowledge.
- Professional written and verbal communication skills.
- Science-based degree (Pharmacy - preferred).
Closing on 13 Feb 2021