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Regulatory Affairs Senior Manager - Biosimilars - United States  

Amgen (company)

Posted on : 01 May 2017

Project Description

The Regulatory Affairs Senior Manager is accountable for the development and execution of regulatory strategies, plans, and marketing applications for biosimilar products.
Key Activities:
Provide regulatory expertise and guidance to the cross-functional teams on regulatory requirements related to global clinical development plans and marketing registrations
Lead development of high quality regulatory documents (CTAs, Marketing Applications, and Responses to Health Authority questions) with the focus on clinical/nonclinical aspects
Lead interactions with Health Authority and facilitate the preparation of briefing materials
Lead global regulatory teams to ensure alignment with regional/local regulatory requirements
Collaborate and effectively communicate with external partners and Amgen affiliates to ensure implementation of global regulatory strategies
Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and long-term planning
Provide regulatory risk assessment to the GRAAS Biosimilars function
Participate in development and execution of risk management and contingency planning
Ensure and lead regulatory compliance for biosimilar products (eg, PMCs and other agency commitments)


Basic Qualifications

Doctorate degree and 2 years of regulatory and/or biosimilars experience
Master’s degree and 6 years of regulatory and/or biosimilars experience
Bachelor’s degree and 8 years of regulatory and/or biosimilars experience
Associate’s degree and 10 years of regulatory and/or biosimilars experience
High school diploma / GED and 12 years of regulatory and/or biosimilars experience

Preferred Qualifications

Regulatory knowledge of global regulations
Regulatory submissions experience
Understanding of drug development
Previous interaction with regulatory agency representatives
Competencies and Skills
Planning and organizational skills
Ability to multi-task
Problem solving
Conflict management
Strong oral and written communication skills
Project management
Excellent interpersonal skills – and ability to work in a team matrix environment
Issue resolution 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.