Amgen Director, Biosimilars CMC Regulatory Affairs in Hong Kong, Hong Kong

Job Description


Facilitate product development and global registration of the Amgen biosimilar portfolio by developing and executing regulatory CMC and analytical similarity strategies

  • Facilitate effective global regulatory agency interactions for product manufacturing and quality programs

  • Define and execute long-term global CMC regulatory plans for licensed biosimilar products


In Summary:

  • All aspects of biosimilar CMC regulatory decisions

  • Strategic leadership and management of CMC regulatory aspects to ensure the development, regulatory approvals, and maintenance of product licenses for the biosimilar product portfolio

  • Coordination of CMC and analytical similarity regulatory activities and deliverables

  • Management of support by Amgen innovative product functions and partners relative to the generation of CMC regulatory documentation

  • Coordination of CMC regulatory requirements with Amgen Biosimilars Operating Unit on the development and execution of biosimilar strategy and achievement of global objectives

At Length:

Regulatory Strategy and Filing

  • Provide expertise and leadership in the development, communication, and implementation of global CMC and analytical similarity regulatory strategies in support of biosimilar goals and product portfolio execution

  • Lead cross-functional teams in development and submission of CMC, quality, and analytical similarity regulatory documents

  • Accountable for generation and submission of CMC and quality regulatory documents, including CTAs, MAs, and RTQs, are developed with high quality, delivered in a timely manner, consistent with the overall biosimilar strategies, and compliant with current regulatory authority requirements

  • Ensure product licenses are maintained per regulatory requirements and consistent with biosimilar strategy and long-term planning

  • Support development and execution of clinical/ non-clinical strategies

Regulatory Interactions

  • Plan, execute and lead agency CMC meetings per regulatory strategy

  • Facilitate ad hoc CMC-related interactions, RTQ responses and meetings

  • Represent the Biosimilars Operating Unit in the coordination and conduct of prior-approval and GMP inspections by regulatory authorities

Regulatory CMC

  • Design, plan and execute regulatory CMC strategies

  • Scientific oversight of development and delivery of analytical similarity regulatory packages that meet biosimilar regulatory requirements

  • Delivery of CMC information in regulatory documents (including CTAs, MAs, analytical similarity assessments, requests for information, CMC related agency interactions)

  • Represent RA CMC on appropriate teams

  • Manage priorities and resources for multiple products

Regulatory Intelligence

  • Monitor, assess and implement regional regulatory requirements

  • Assess impact of regulatory decisions for competitive products

  • Generate and communicate biosimilar intelligence to the Biosimilars Operating Unit and Amgen innovative teams as appropriate

Biosimilars Policy

  • Provide subject matter expertise to GRAAS Biosimilar Policy function


  • Support vendor oversight and management for regulatory CMC operations

  • Exchange biosimilar CMC and analytical similarity regulatory requirements with regulatory colleagues on an ongoing basis

Requirements and Qualifications:

Doctorate degree & 4 years of directly related experience


Master's degree & 8 years of directly related years


Bachelor's degree & 10 years of directly related experience

4+ years of managerial experience directly managing people and/or leadership experience leading

teams, projects, programs or directing the allocation of resources

  • Exceptional planning and organizing abilities

  • Strong leadership, negotiation, and collaboration skills

  • Strong problem solving abilities

  • Strong oral and presentation abilities

  • Strong written communication skills

  • Command skills

  • Customer focus

  • Ability to direct others

  • Comfort with managing multiple activities

  • Making complex decisions

  • Setting priorities

  • Dealing with ambiguity

  • Action oriented

  • Flexibility with day-to-day requirements

  • Conflict management

  • Building effective teams

  • Excellent interpersonal, organizational, supervisory skills

  • Ability to provide direction, support and coaching for team members