Regulatory Affairs Manager 注册经理

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 Accountability 1: Regulatory Strategy and Planning
? Working with the General Manager of Greater China, define the Greater China Regulatory Affairs strategies and develop local RA functional business plans in collaboration with General Manager and APAC Regulatory Director/Manager.
? Lead input into the local regulatory affairs budget and forecasting processes to support accurate planning
? Responsible for gaining and providing regulatory intelligence to CCY and CLTD.

Accountability 2: Deliver product registrations on time and within budget
? Define and communicate the product registration plans for Greater China in line with Marketing and Sales expectations
? Define the requirements for product registration plans for China and communicate to CAP RQR to ensure technical documentation support expeditious product submissions
? Establish and maintain strong relationships with SFDA and CMDE representatives to maintain visibility and engage dialogue regarding submissions in process.
? Facilitate any local testing of product to China standards
? Prepare dossiers for submission to SFDA and CMDE and mange their review through to approval
? Contribute, establish and maintain effective project management system for Greater China to share Regulatory Affair project relevant information to accelerate product approval
? Participate in any discussions with (China Regulatory Body) regarding any additional requirements, specifications or data which may be requested by the (SFDA and CMDE) for product approval.

Accountability 3: Product Definition, Development and Realisation
? Champion the Greater China regulatory requirements throughout Cochlear’s product innovation process (PIP) and product lifecycle to support efficient and effective product development, and market access.

Accountability 4: Product Continuity
? Support the Greater China marketing strategies by managing the successful and timely and introduction of new/ modified products across the Greater China Region
? This includes the creation of technical dossiers appropriate for the regional market submissions, coordinating support for all subsidiaries, offices and distributors and working with regulatory authorities within Greater China.
? Define and lead implementation of plans to maintain product and relevant importation licenses/ requirements throughout the product lifecycle across Greater China.

Accountability 5: Regulatory Compliance
? Keep up to date with changes to regulations and standards and advise regional and global colleagues of the implications of such changes
? Evaluate risk and safety issues and recommend regulatory solutions during any clinical study development and implementation
? Ensure that products manufactured and/or distributed by Cochlear Greater China and Asia Pacific are in compliance with applicable laws and regulations
? Ensure copy review, advertising and promotional communications comply with Company and legislative requirements.

Accountability 6: Industry and Business Improvement
? Develop and maintain relationships with relevant industry association, regional regulatory authorities and Cochlear’s Regulatory Affairs professionals to maintain knowledge base and influence the development of regulatory processes and systems towards harmonization and efficient product registration