The purpose of this position 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.
This position will support:
Global regulatory CMC activities relevant to the successful execution and implementation of biosimilar CMC regulatory strategies and plans
Development of CMC and analytical dossiers required for registration of biosimilar products
Management of long term CMC planning and regulatory CMC submissions for licensed products
Regulatory Strategy and Filing
Provide CMC regulatory oversight in the development, communication, and implementation of global regulatory strategies in support of the Regulatory Biosimilars Team
Ensure regulatory documents (including analytical similarity packages and quality sections for briefing books, CTAs, MAs, annual reports, manufacturing amendments, and other documents) are developed with high quality and delivered in a timely manner, as directed by the RA CMC Lead
Support cross-functional teams in development and submission of Quality/Operations/CMC regulatory documents, including responses to questions from regulatory authorities
Maintain the CMC sections of product licenses per regulatory requirements, including updates
Support CMC-related agency interactions
Represent RA CMC at relevant team meetings as directed by the RA CMC Lead
Collaborate with other Regulatory Department functions on biosimilar issues, (eg, CMC, Regulatory Operations, Devices)
Comply with Amgen Regulatory CMC processes
Generate and communicate CMC intelligence to the Amgen biosimilars community as directed by the RA CMC Lead
Support regulatory risk assessments by the Regulatory Biosimilars function and CMC filing teams
Communicate CMC issues, progress, and metrics to the Regulatory Biosimilars Team
Represent the Regulatory Biosimilars Team on internal Amgen CMC committees
Master’s degree and 3 years of regulatory, CMC, manufacturing, testing or process/product development experience
Bachelor’s degree and 5 years of regulatory, CMC, manufacturing, testing or process/product development experience
Associate’s degree and 10 years of regulatory, CMC, manufacturing, testing or process/product development experience
High school diploma / GED and 12 years of regulatory, CMC, manufacturing, testing or process/product development experience
Planning and organizing abilities
Managing multiple activities
Problem solving abilities
Dealing with ambiguity
Flexibility with day-to-day requirements
Strong oral and written communication skills
Excellent interpersonal and organizational skills
Ability to provide support 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.
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.