公司： 康茂峰医药科技有限公司
上海办公室地址：上海市浦东新区友诚路149号SK大厦办公楼4302B

作为中国领先的医药服务公司，康茂峰近二十年来一直与跨国企业合作。我们专注于提供创新、合规、高效的解决方案，以支持药物开发、注册申报和生命周期管理。我们对卓越和客户协作的承诺，使我们成为全球制药行业值得信赖的合作伙伴。

职位概述：
我们正在寻找一位充满活力且具有战略眼光的eCTD业务负责人，来领导和拓展我们的电子通用技术文档提交服务能力。该职位对于推动业务增长、加强客户关系以及确保最高标准的法规合规性和运营卓越性至关重要。
我们心目中的您：兼具深厚的技术专长和强大的商业头脑、出色的沟通能力，以及开发新客户合作伙伴关系的成功经验。

岗位职责：
1、 领导和管理eCTD运营团队，确保为国内外市场的客户提供及时、高质量的注册申报服务。
2、制定并实施战略计划，以拓展康茂峰的eCTD服务范围和市场影响力。
3、作为关键的客户代表，与现有及潜在的跨国企业和生物技术客户建立并维护关系。
4、识别并把握新的业务机会，通过客户获取和合同谈判直接为公司收入增长做出贡献。
5、 就全球eCTD趋势、法规要求和最佳实践，向内部团队和客户提供专家指导。
6、与法规事务、信息技术、翻译、质量等跨职能部门合作，优化申报流程和技术。
7、指导和发展团队成员，培育持续改进、创新和专业成长的文化。
8、确保所有运营符合中国和国际相关法规标准（如：NMPA、FDA、EMA）。

任职要求：
1、生命科学、药学、法规事务或相关专业本科及以上学历。研究生学历优先。
2、至少8年以上eCTD运营、注册申报或药品法规事务领域的专业经验，并拥有成功的业绩记录。
3、出色的沟通和演示技巧，能够清晰且有说服力地向不同受众阐述复杂的技术信息。
4、 强大的领导和管理能力，包括团队建设、绩效管理和战略规划方面的经验。
5、在制药或CRO行业内，具备业务拓展、客户获取和合同谈判方面的成功经验。
6、精通英语（书面和口语）对于国际客户互动和全球协作至关重要。
7、 熟悉注册申报软件和工具，并扎实理解中国及全球的法规指导原则。

加入康茂峰的理由：
1、 有机会与在中国服务跨国企业拥有近20年专业经验的行业知名领导者合作。
2、 在塑造eCTD服务未来和推动业务增长方面发挥关键作用。
3、协作、创新且专业的工作环境。
4、具有竞争力的薪酬方案、绩效激励和职业发展机会。

Company: Willingjet Life Science LTD. （康茂峰）
Shanghai Office Address: Unit 4302B, SK Tower Office Building, No. 149 Youcheng Road, Pudong New District, Shanghai
As a leading pharmaceutical services company in China, WillingJet has been partnering with multinational corporations (MNCs) for nearly two decades. We specialize in providing innovative, compliant, and efficient solutions to support drug development, regulatory submissions, and lifecycle management. Our commitment to excellence and client collaboration has established us as a trusted partner in the global pharmaceutical industry.
Position Overview:
We are seeking a dynamic and strategic Director of eCTD Operations to lead and expand our electronic Common Technical Document (eCTD) submission capabilities. This role is critical in driving business growth, enhancing client relationships, and ensuring the highest standards of regulatory compliance and operational excellence. The ideal candidate will combine deep technical expertise with strong business acumen, exceptional communication skills, and a proven ability to develop new client partnerships.
Key Responsibilities:
• Lead and manage the eCTD operations team, ensuring timely, high-quality regulatory submissions for clients across China and international markets.
• Develop and implement strategic plans to expand WillingJet’s eCTD service offerings and market presence.
• Act as a key client-facing representative, building and maintaining relationships with existing and potential MNC partners and biotech clients.
• Identify and secure new business opportunities, contributing directly to company revenue growth through client acquisition and contract negotiations.
• Provide expert guidance on global eCTD trends, regulatory requirements, and best practices to both internal teams and clients.
• Collaborate with cross-functional departments, including Regulatory Affairs, IT, Translation, and Quality, to optimize submission processes and technology.
• Mentor and develop team members, fostering a culture of continuous improvement, innovation, and professional growth.
• Ensure all operations comply with relevant Chinese and international regulatory standards (e.g., NMPA, FDA, EMA).
Qualifications:
• Bachelor’s degree or higher in Life Sciences, Pharmacy, Regulatory Affairs, or a related field. Advanced degree preferred.
• Minimum of 3 years of professional experience in eCTD operations, regulatory submissions, or pharmaceutical regulatory affairs, with a proven track record of success.
• Excellent communication and presentation skills, with the ability to articulate complex technical information clearly and persuasively to diverse audiences.
• Strong leadership and management capabilities, including experience in team building, performance management, and strategic planning.
• Demonstrated ability in business development, client acquisition, and contract negotiations within the pharmaceutical or CRO industry.
• Proficiency in English (both written and spoken) is essential for international client interactions and global collaboration.
• Familiarity with regulatory submission software and tools, as well as a solid understanding of Chinese and global regulatory guidelines.
Why Join Willingjet?
• Opportunity to work with a reputable industry leader with nearly 20 years of expertise in serving MNCs in China.
• Play a pivotal role in shaping the future of eCTD services and driving business growth.
• Collaborative, innovative, and professional work environment.
• Competitive compensation package, performance incentives, and career development opportunities.
How to Apply:
If you are a results-driven eCTD professional with a passion for excellence and business growth, we invite you to apply by sending your resume and a cover letter outlining your relevant experience and achievements to [***************************]. Please include “Director of eCTD Operations Application” in the subject line.