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

Job Description

Accountibilities:

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

Responsibilities

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

Collaboration

  • 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

OR

Master's degree & 8 years of directly related years

OR

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