Senior Associate Regulatory Affairs – Regional Regulatory Professional – US

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-27346
Global Regulatory Affairs provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules.
The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.
Key Activities:
Assist Regional Regulatory Lead (RRL) to support regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations)
Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications
Review regional component of the Global Regulatory Plan and provide input to operational deliverables; perform regulatory research to support the development of content for Global or Regional regulatory plan as delegated by the Global or Regional regulatory lead
Actively support regulatory compliance and ensure compliance of submissions to regulatory agencies
Assist the Global or Regional Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label and managing the process for responding to regulatory agency questions.
Participate in GRT and assist the Global or regional regulatory lead in meeting management (e.g., agendas and minutes for GRTs) to advance regulatory knowledge of the product and processes
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Support the development and execution of GRT goals
Basic Qualifications
Master's degree
Bachelor's degree and 2 years of regulatory or drug development experience
Associate's degree and 6 years of regulatory or drug development experience
High school diploma / GED and 8 years of regulatory or drug development experience
Preferred Qualifications
Master's degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum
Regulated industry, science or clinical practice experience
Good communication skills - both oral and written
Organizational skills - detail oriented and can deal with frequent changes in product activity
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.

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