Career Category

Job Description

Job Summary: Leads the development and articulation of Amgen's positions on regulatory policies in the JAPAC region that impact Amgen's business within the JAPAC region and across the regions. The scope of leadership responsibilities span policy topics..  Engages on cross-functional teams to develop strategic/long-term plans for the development and implementation of policies. Engages regulatory authorities and industry and professional associations at the policy level.

Key Activities:

Ensures that Amgen's regulatory, safety and R&D policy positions are successfully represented to inform policy development and implementation

Fosters a reputation with JAPAC regulators as being science-based, reliable and trustworthy by advocating sound for policies

Leverages key relationships, internally and externally (e.g. NMPA ,MHLW/PMDA and other national regulatory authorities, international organizations, e.g. ASEAN and industry associations in the JAPAC region) to advance Amgen's position related to regulatory and safety policy

Provides internal stakeholders (e.g., Global Government Affairs, R&D, Commercial, Legal, Regional and Local leadership in JAPAC) with a strategic regulatory and safety policy perspective

Assists and advises senior leadership in selecting issues, establishing priorities and developing and executing regulatory policy advocacy plans

Assists in creating the necessary infrastructure/processes for developing the regulatory policy function

Ensures direct and dotted line staff are compliant with required training and SOPs, and conducts annual review of staff training records for direct line reports.

Knowledge and Skills

Basic:

Comprehensive knowledge of the biopharmaceutical or medical device industry, drug development, and regulatory and/or business strategies and plans.
Knowledge of the specific domains within Regulatory and Safety
Presentation and interpersonal communication skills

Preferred:

Relationships with industry stakeholders (e.g., trade associations, biopharmaceutical companies, NMPA, MHLW/PMDA, and other national competent authorities)
Knowledge of Amgen Commercialization Process

Education & Experience

Basic:

Doctorate degree and 4 years of directly related experience
OR
Master’s degree and 8 years of directly related experience
OR
Bachelor’s degree and 10 years of directly related experience

Preferred:

Project Management

Experience in a government, regulatory or policy capacity