Senior Associate Regulatory Affairs (1-year Fixed (UZ106)

Amgen

  • Buenos Aires
  • Permanente
  • Tiempo completo
  • Hace 1 día
**HOW 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:- 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**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.**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.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.

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