Regulatory Affairs Manager, 7-9 month, CBD

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.