JAPAC Strategic Planning & Operations Sr. Manager Regulatory Affairs

Amgen; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

A leading company in the biotech sector seeks a Regulatory Partner to support the JAPAC Regulatory organization. This role involves driving departmental initiatives, collaborating with various teams, and ensuring effective communication with senior management. Candidates should demonstrate strong communication skills and a solid understanding of regulatory practices.

Qualifications

• Experience writing and presenting clearly to Senior Management.
• Extensive project management/project planning experience.
• Knowledge of Good X Practices and international regulations.

Responsibilities

• Facilitate department goal setting and track deliverables.
• Identify and resolve JAPAC regulatory issues.
• Manage and execute daily assigned tasks as requested.

Skills

Strong verbal / written communication skills

Strong problem-solving skills

Job description

Career Category Regulatory Job Description

Partner with other GRAAS SPOs to provide flexible support across the JAPAC Regulatory organization, driving and implementing department goals and initiatives, supporting JAPAC Regulatory leaders in strategic planning and execution of department needs, and collaborating cross-functionally.

Responsible for:

• Identifying operational objectives for multiple teams within the JAPAC region

• Identifying JAPAC Regulatory issues and driving resolution

• Developing and maintaining business

relationships across affiliates within GRAAS and the JAPAC Region

• Representing JAPAC Regulatory on process improvement initiatives

Key Activities:

• Facilitate Department goal setting and initiatives and track deliverables
• Act as a sounding board/advisor to the GRAAS JAPAC leader on key activities and issues
• Proactively identify and resolve upcoming issues within the Department, and at interfaces with other departments
• Develop and/or drive execution of leadership communication plan
• Facilitate preparation of internal presentations including All-Staff presentations, reports on business performance
• Represent the goals for the Department and partner with other functions such as Human Resources and Finance in support of Departmental objectives
• Work with JAPAC & GRAAS leaders to organize staff meetings to achieve objectives of the organization
• Identify lead or contribute to initiatives/process improvement opportunities as designated
• Assist in interactions at senior level forums as needed
• As Decision Making Superuser, drive effective decision making in the Department
• Manage and execute daily assigned tasks as requested

Knowledge
• Knowledge to represent and evaluate strategies for Function and to critically evaluate advice
• Knowledge of Good X Practices, international regulations and guidelines, as applicable
• Knowledge of continuous improvement principles
• Experience with external benchmarking, including Amgen processes and metrics
• Extensive project management/project planning experience overseeing program deliverables, budgets, and timelines
• Experience writing and presenting clearly to Senior Management audience

Skills
• Strong verbal / written communication skills, including listening & presentation skills
• Strong problem-solving skills

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