Manager, Regulatory Affairs 醫藥法規經理

Essential Duties and Responsibilities: Your primary responsibility will be to lead and manage all regulatory affairs activities, ensuring the development and execution of robust regulatory strategies throughout the product development and submission process. This role demands strong leadership to effectively guide a team of regulatory professionals, as well as excellent communication skills to engage with regulatory authorities and external stakeholders. 1.. Regulatory Submission Management - Coordinate, prepare, review, and manage regulatory submissions (e.g., INDs, NDAs, variations) to ensure timely approvals. - Prepare and coordinate responses to regulatory agency inquiries and requests for information. 2.. Regulatory Strategy Development - Develop and implement regulatory strategies for new and existing products across all stages of the product lifecycle. - Provide strategic and technical guidance on regulatory requirements for projects at various development stages. 3.. Compliance Oversight - Ensure company products comply with relevant domestic and international regulatory requirements and guidelines. - Evaluate and update company policies and procedures to maintain regulatory compliance. 4.. Cross-Functional Collaboration - Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to resolve regulatory issues and ensure ongoing compliance. - Advise internal teams on regulatory requirements related to product quality, safety, and efficacy. 5.. Stakeholder Engagement - Represent the company in meetings and negotiations with regulatory agencies and external stakeholders. - Foster relationships with regulatory authorities and industry associations. 6.. Training & Team Leadership - Deliver training and guidance to internal teams on regulatory requirements and changes in the regulatory landscape. - Mentor and support the professional development of junior regulatory staff.