监管专家

Job Overview:
Merck Shanghai Company Ltd. is seeking a highly motivated and knowledgeable Regulatory Expert to join our Regulatory Business Transformation (RBT) team in China. In this pivotal role, you will provide operational and strategic regulatory support to our business units, ensuring compliance while driving innovative solutions and continuous process improvements. You will act as a key liaison between internal and external stakeholders, facilitating efficient and compliant product launches in a dynamic and fast-paced environment.
Responsibilities:
• Serve as the primary regulatory liaison for business units, aligning regulatory strategies with business objectives.
• Lead Regulatory & Compliance Feasibility Assessments (RCFA) and deliver consultancy services to address regulatory challenges.
• Support RBT business partner projects and decision points in Legal Entity Extension workflows.
• Manage clean-up requests from Jira through TrackWise and ensure seamless operational workflows.
• Collaborate with Regulatory & Compliance (R&C) teams to maintain effective communication and partnership.
• Engage in negotiations with third-party vendors and partners, ensuring adherence to regulatory standards.
• Contribute to strategic projects by providing data analysis, management, and innovative solutions.
• Develop expertise in global regulations for GHS, Trade Compliance, and Chemical Registration to support business strategies.
Qualifications:
• Education:
o Bachelor’s, Master’s, or PhD in Natural Sciences, Life Sciences, Data Science, or a related field; MBA or equivalent is a plus.
• Experience:
o Minimum of 2 years of professional experience in the Life Sciences industry with demonstrated regulatory expertise.
• Technical Skills:
o Proficiency in SAP (EHSM module), Palantir, Tableau, and Project Management tools. (preferred)
o Programming skills (e.g., Python, SQL) and familiarity with Jira and TrackWise. (preferred)
o Expertise in MS Office, data management, reporting, and quality management documentation.
• Certifications (Preferred):
o Six Sigma Belt, PMP, SCRUM, or similar credentials.
• Soft Skills:
o Strong analytical mindset with a structured working style.
o Team-oriented and empathetic, with excellent communication skills in a global, multicultural setting.
o Result-driven, detail-oriented, and curious with a passion for innovation and optimization.
• Language:
o Fluency in English (required); additional language skills are a plus.