Amgen Regulatory Affairs Manager in Thousand Oaks, California
Amgen is seeking a Regulatory Affairs Manager for our Biosimilars group. This person will sit in our Thousand Oaks, CA main campus.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. We have a presence in more than 75 countries worldwide and have reached millions of people in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses.
The Regulatory Affairs Manager – Biosimilars will be responsible for the following:
Assist with development of high quality regulatory documents (CTAs, Marketing Applications, and Responses to Health Authority questions) with the focus on clinical/nonclinical aspects
Assist with developing and executing global clinical/non-clinical development strategies
Assist in providing regulatory risk assessment to the GRAAS Biosimilars function
Review and contribute to investigator’s brochures, clinical study reports, and related regulatory documents required to support product development and registration
Assist with development of global product labels and core data sheets
Assist with planning and executing Health Agency meetings, including generation and submission of briefing books and meeting preparations
Collaborate and effectively communicate with partners and Amgen affiliates as required to ensure implementation of global regulatory strategies
Represent Global Regulatory Affairs on cross-functional development teams
• Doctorate degree
• Masters’ degree and 3 years of regulatory and/or biosimilars experience
• Bachelors’ degree and 5 years of regulatory and/or biosimilars experience
• Associates degree and 10 years of regulatory and/or biosimilars experience
• High school diploma / GED and 12 years of regulatory and/or regulatory experience
Regulatory knowledge of global regulations
Regulatory submissions experience (IND’s, BLA experience)
Experience with strategies and responses to Health Agency Requests
Understanding of drug development
Previous interaction with regulatory agency representatives
Strong oral and written communication skills
Ability to understand and communicate scientific and clinical information
Ability to anticipate and prevent potential issues
Ability to communicate regulatory strategies and requirements
Ability to provide direction and support for team members
Planning and organizational skills
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.