Manager, Regulatory Affairs (APAC)

Key Responsibilities:

Key activities will revolve around leading regulatory activities for both the diagnostic agent, camera and cloud base platform across the specified region.

• Preparation and delivery of high-quality regulatory submissions and submission management plans for global regulatory agencies.
• Independently prepare regulatory submissions and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and work to support the product portfolio.
• Managing regulatory issues, maintaining submission information in relevant systems, tracking regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
• Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.
• Authoring and/or coordinating submission activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinating and contributing to responses to agency queries and performing quality review of regulatory submissions.
• Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by products.
• Assisting the Manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
• Maintenance of existing global regulatory approvals.
• Prioritizing and independently completing assigned workload appropriately.
• Managing and contributing to regulatory affairs-related projects, initiatives and actions.

Experience and Capabilities:

• Bachelor's degree or equivalent/graduate degree preferred in a science (Biology, Chemistry, Pharmacy or related science) and/or technical discipline.
• Minimum of 5 years of hands-on Regulatory/Chemistry, Manufacturing and Controls (CMC) authoring experience preferable (initial registrations or post-approval variations).
• Experience managing projects is preferable.
• Excellent verbal, written and presentation skills.
• Knowledge of local market dynamics and business practices in Asia.

Core Competencies / Attributes:

• Action and results-orientated to achievement of goals and objectives.
• Experience with leading and participating in several projects concurrently.
• Ability to accurately scope projects and consider the full impact of decisions and actions taken.
• Excellent interpersonal skills and ability to participate with cross functional teams in projects and innovation.
• Strong presentation skills, able to engage people in technologies, products & services.
• Functional expert in regulatory affairs with a passion for excellence.
• Attention to detail and accuracy – essential.
• Maintains direction & focus through proactive planning & organized approaches to work.
• Resilient to objections, pressure and change in a fast-moving industry.