Job Scope:
· Is agile and up to date on regulation changes and assesses their impact on the EPD business and products.
· Monitors and disseminates information on changes related to HSA and APAC (laws & regulations affecting registration, manufacture, and distribution) to regional/global RA and the commercial team.
· Develops and provides registration strategies with its timeline, way to accelerate, anticipate potential risks with mitigation plan of assigned products/projects handling complicated issues, seeking guidance where appropriate.
· Handling new product submissions and product lifecycle management, variations, through authority, and cross-functional engagement to ensure input from cross-functional team members and issues regional regulatory plans as appropriate.
· Prepares and maintains local SOPs and policies relevant to Regulatory Affairs to comply with the company's Global SOPs & policies and local regulation.
· Provides regulatory input and support for marketing plans, product launches, and other cross-functional activities.
· Reviews, and provides input and approval on local promotional materials, product information, packaging, and labels to ensure regulatory compliance.
· Maintains and strengthens good relationships with the Health Sciences Authority of Singapore (HSA).
· Liaises and negotiates with the relevant authorities to facilitate and secure expeditious regulatory approvals.
· Attendance at project teams representing APAC EPD RA of assigned products/projects as appropriate.
· Manage strategy for responding to regulatory agency queries, ensuring scientific dossier content and consistency of scientific content and Company position across APAC.
· Responsible for ensuring the accuracy and quality of documentation.
· Manage the preparation and review of technical strategic regulatory documentation for agency submission.
· Monitor actual vs planned activities and timelines.
· Identify issues impacting project progression and work with the other functions and reporting line to recommend improvements to correct or accelerate project progression
Requirements:
· At least 5 years of regulatory experience in the pharmaceutical industry including OTC, Health supplements, Pharma, and vaccines.
· Required Singapore registered Pharmacist who has access to PRISM (HSA online system).
· Exposure or experience to regional RA is highly preferable.
· Strategic & conceptual thinking, intrapreneurship, prioritization.
· Agility, initiative, integrity, risk-taking, the anticipation of potential issues with mitigation proposal.
· Detailed and able to handle ambiguities.
· Leadership, and collaborative work with cross-functional & cross-level, project management skills.
· Fluent in both verbal and written. Ability to communicate with all levels of management and across different cultural backgrounds.
· Knowledge of local & APAC regulations.
· Well-developed interpersonal, communication, and negotiation skills.
Additional Information:
· Contract duration: 7-9 month, maternity coverage
· Commencement Date: March 2025
· Working days and hours: Mon to Friday, 9am to 6pm
· Location: Duo Tower, Bugis MRT
