Director Regulatory Affairs - Biosimilars

Amgen is seeking a Director Regulatory Affairs (RA) - Global Biosimilars who will provide global regulatory leadership and support to the Amgen Biosimilars Operating Unit. This position will be located at Amgen's main campus in Thousand Oaks, CA.

The purpose of this group is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans.

The Director Regulatory Affairs - Global Biosimilars will facilitate product development and global registration of the Amgen biosimilars portfolio by developing and executing regulatory strategies and will ensure that regulatory agreements for clinical trials are acquired and maintained. They are also responsible to achieve desired global labelling that are compliant with regulatory requirements and will manage effective interactions with regulatory authorities, particularly with FDA, EMA, and PMDA. Support global regulatory registration partnering with regulatory affairs in Amgen affiliates.

Additional responsibilities include:

• Strategic leadership and management of regulatory aspects required by the Amgen Biosimilars Operating Unit to ensure the development, regulatory approvals, maintenance, and long-term planning of product licenses for the biosimilar product portfolio
• Management of activities and deliverables provided by other GRAAS and Amgen functions to support regulatory objectives of the Biosimilars Operating Unit
• Providing leadership to filing and labeling teams

Regulatory Strategy & Filing

• Provide expertise and leadership in the development, communication, and implementation of approved global regulatory strategies and plans in support of biosimilar goals and product portfolio execution
• Lead and provide regulatory direction to cross-functional teams
• Ensure regulatory documents are developed with high quality, delivered in a timely manner, consistent with biosimilars strategies, and compliant with current global regulatory authority requirements
• Ensure all filings meet regulatory requirements
• Ensure development and execution of clinical/ non-clinical strategies, including regulatory review, input and advice for study concept documents, study protocols, informed consent forms, statistical analysis plans, clinical study reports, and related regulatory documents required to support product development and registration
• Identify process needs to meet internal challenges

Regulatory Interactions

• Plan, execute and lead agency meetings per regulatory strategy
• Lead the generation and submission of briefing books to support regulatory interactions
• Facilitate ad hoc interactions, RTQ responses and meetings
• Ensure coordinated planned and ad hoc contacts with regulatory authorities on the development and registration of biosimilar products

Regulatory Intelligence

• Monitor, assess and implement regional regulatory requirements
• Review and assess impact of regulatory decisions for competitive products
• Ensure that biosimilar regulatory intelligence gained by the Biosimilars Regulatory Function is communicated to the Biosimilars Operating Unit, other Amgen functions and partners as appropriate

Biosimilars Policy

• Provide subject matter expertise to GRAAS Biosimilars Policy function as required

Collaboration

• Ensure that regional regulatory activities are appropriately coordinated with Amgen affiliates
• Support vendor oversight and management for regulatory operations
• Escalate regulatory issues, progress, and metrics to the GRAAS Biosimilars function
• Represent Biosimilars Regulatory Affairs on committees, as necessary
• Share insights on biosimilar regulatory requirements with colleagues

Basic Qualifications

Doctorate degree and 4 years of experience in the development and implementation of global regulatory strategies, submissions, and plans

OR

Master's degree and 8 years of experience in the development and implementation of global regulatory strategies, submissions, and plans

OR

Bachelor's degree and 10 years of experience in the development and implementation of global regulatory strategies, submissions, and plans

AND

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

Preferred Qualifications

• Comprehensive understanding of Regulatory and Safety functional activities and how they affect projects and processes
• Regulatory experience with product filings
• Experience interacting and communicating with senior executives and teams regarding strategic issues to ensure expectations are understood
• Experience communicating and clearly presenting strategic and business issues
• Experience leading teams and projects in a global, complex, dynamic, regulated matrix environment
• Ability to understand and communicate scientific and clinical information
• Ability to anticipate and prevent potential issues
• Ability to manage and mentor others
• Cultural awareness and sensitivity to achieve results across different regions

Competencies

• Exceptional planning and organizing abilities
• Strong leadership, negotiation, and collaboration skills
• Strong problem-solving abilities
• Strong oral and presentation abilities
• Strong written communication skills
• Ability to supervise and mentor 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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.