Amgen Executive Director Regulatory Affairs, Biosimilars in Thousand Oaks, California

The Executive Director, Global Biosimilars Regulatory Affairs role is to support the regulatory, product development and commercialization needs of the Amgen Biosimilars Business Unit through detailed development and implementation of global regulatory strategies, submissions and plans.

Job Summary:

  • Provide leadership and management of the Biosimilars Regulatory Team by overseeing the development and execution of global regulatory strategies and plans for the development and commercialization of Amgen biosimilar products

  • Ensure appropriate regulatory input is provided to the Biosimilars Business Unit

  • Lead and manage global regulatory agency interactions

  • Facilitate patient access to Amgen products by executing on regulatory filing plans

Responsible for:

  • Accountable for execution of biosimilar regulatory product strategies

  • Leadership and management of regulatory aspects required by Amgen Biosimilars Business Unit to ensure the development, commercialization, and long-term planning of biosimilar products

  • Oversight of activities and deliverables provided by other GRAAS and Amgen functions to support regulatory development, approval, and maintenance of Amgen biosimilar products

  • Coordination with Amgen Biosimilars Business Unit to develop and execute biosimilar strategies and achieve global objectives

Key Activities:

Strategy and Execution

  • Oversee development and execution of global biosimilar CMC and Clinical regulatory strategies and plans

  • Advise regulatory staff in development and implementation of product development and filing strategies and plans

  • Review and approve regulatory documents and ensure they are consistent with biosimilar strategies, developed with high quality, delivered in a timely manner, and meet regulatory authority requirements

  • Ensure clinical trial applications, marketing applications, and licensed products are maintained per regulatory requirements and consistent with biosimilar strategy

Regulatory Agency Interactions

  • Oversee regulatory agency interactions and ensure that they are appropriate and effective

  • Ensure global compliance with agency commitments and regulatory requirements for products in development and that are licensed

  • Build relationships with regulatory authorities

  • Work externally to influence the regulatory environment in line with Amgen compliance and policy requirements and biosimilar priorities

Management

  • Provide managerial leadership and direction to the Biosimilars Regulatory Team and ensure appropriate prioritization of resources to achieve goals

  • Recruit and retain talented regulatory affairs professionals. Provide coaching, mentoring, and development of staff

  • Ensure staff are compliant with Amgen corporate and GRAAS departmental training

  • Disseminate relevant information to the team as appropriate

  • Participate in budget and headcount planning

  • Sponsor process improvements, initiatives, and training

Biosimilar Policy

  • Participate in identifying and facilitating divisional policy needs with the Amgen and GRAAS Biosimilar Policy functions

  • Actively engage in key policy issues

Collaboration

  • Ensure appropriate, and participate in, vendor oversight and management for regulatory support and operations

  • Act as primary GRAAS contact for biosimilar-related partnerships

  • Exchange biosimilar information with regulatory colleagues on an ongoing basis

Knowledge and Skills:

Comprehensive understanding of Regulatory, Safety, Clinical, CMC, and Analytical functional activities and how they affect biosimilar projects and processes

  • Global regulatory experience with product filings and long-term planning

  • Experience interacting and communicating with senior executives regarding strategic issues

  • Experience communicating and clearly presenting strategic and business issues

  • Experience leading teams and projects in a global, complex, dynamic, regulated matrix environment

  • Serves as a technical authority within the organization

  • Deep knowledge of strategic management models and frameworks

Competencies:

  • Leadership skills

  • Directing others

  • Planning and organizing abilities

  • Ability to manage multiple activities

  • Making complex decisions

  • Problem solving abilities

  • Setting priorities

  • Dealing with ambiguity

  • Organizational savvy

  • Action oriented

  • Conflict management

  • Building effective teams

  • Oral and written communication skills

  • Professional negotiation, collaboration and leadership skills

  • Interpersonal, organizational, supervisory skills

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

Education & Experience - Basic Qualifications

Doctorate degree and 6 years of regulatory affairs experience

OR

Master's degree and 10 years of regulatory affairs experience

OR

Bachelor's degree and 12 years of regulatory affairs experience

AND

6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Education & Experience -Preferred Qualifications

  • Degree in Life Sciences, Engineering, or related field

  • 10 years of related experience in the pharmaceutical/biotechnology industry

  • 7 years Regulatory and/or Safety experience

  • 15 years of organizational leadership experience

  • Formal strategy experience

  • Experience working in a global team

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.