Senior Associate Regulatory Affairs (1-Year Fixed Term) page is loaded Senior Associate Regulatory Affairs (1-Year Fixed Term) Apply remote type Remote locations Argentina - Buenos Aires time type Full time posted on Posted Today job requisition id R-184490 Career CategoryRegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.
Key responsibilities include: Ensure life-cycle management for local products and production as local regulatory for selected products (biologics and synthetic).
Support RA senior staff, collaborate with the product teams, international regulatory, local QA/QC and supply chain. Interphase when specific strategies or activities that impact a product are required.
Revise and Approve Promotional Material
Works within Amgen systems for document management
Collaborate with R&D and Operations personnel to coordinate preparation of regulatory filings, identification of issues and factors that may impact a regulatory strategy or activity including:
Marketing applications for biological medicines
Post-market supplements
Product Renewals
Skills / Competencies: ANMAT (National Drug and Medical Technology Administration)
Strong interpersonal skills
High accountability to follow through projects.
Able to work independently and proactively.
Strong computer skills, including word processing, database document repository and project management software.
Basic Qualifications: Associate's degree and / or 1 year Regulatory experience (Desirable)
Master's degree OR
Bachelor's degree and 2 years of experience in similar positions on a big pharmaceutical company OR
Associate's degree and 6 years of experience in similar positions on a big pharmaceutical company Or
High school diploma / GED and 8 years of experience in similar positions on a big pharmaceutical company.
Proficiency in English, both in oral and written communication.
Preferred Qualifications: Regulatory experience.
1 year's regulatory experience in RA in the Pharmaceutical/Biotechnology industry, preferably biologics.
Commercial product life-cycle management experience
Commercialization or marketing application experience.
THRIVE! Some of the vast rewards of working here As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
Full support and career-development resources to expand your skills, improve your expertise, and maximize your potential along your career journey.
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor.
Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation
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About UsAmgen 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 biologics manufacturing 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.
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