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

Basic Qualifications

  • Doctorate degree

OR

  • Masters' degree and 3 years of regulatory and/or biosimilars experience

OR

  • Bachelors' degree and 5 years of regulatory and/or biosimilars experience

OR

  • Associates degree and 10 years of regulatory and/or biosimilars experience

OR

  • High school diploma / GED and 12 years of regulatory and/or regulatory experience

Preferred Qualifications

  • 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.

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.