C-607 | Sr Associate Regulatory Affairs (1-Year Fixed Term)

C-607 | Sr Associate Regulatory Affairs (1-Year Fixed Term)

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**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.
**Sr Associate Regulatory Affairs **(**1-Year Fixed Term)**:**Live****What you will do****Key responsibilities include,



but are not limited to**:- Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements.- Contribute, implement, and execute the filing plan for Mexico where applicable.- Prepare, review & approve of source text for Mexico country specific labeling.- Review & approve promotion and non-promotion materials- Communicate relevant information to team(s) in advance- Participate and give input in local regulatory process improvements initiatives.- Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.- Update, maintain internal regulatory systems and tracking tools in accordance with internal policies and standard operating procedures.- Develop & execute the local strategy to obtain the new Marketing Authorizations of the assigned business unit, ensuring compliance with local and current regulations and procedures.- Analysis of technical, scientific, and legal information to prepare dossiers of innovative products,



complying with all applicable requirements and guidelines, avoiding preventions by the health authority (New Marketing Authorizations, technical and administrative variations, and renewals).
**Win**:**What we expect of you**We are all different, yet we all use our unique contributions to serve patients.
The professional we seek has these qualifications.
**Basic Qualifications**:- Master's degree O- 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 of experience in similar positions on a big pharmaceutical company.- Proficiency in English, both in oral and written communication.




**Preferred Qualifications**:- Knowledge and experience in Mexican regulation relating to medicinal products and diverse portfolio of small molecules, innovative biotechs, biosimilars and orphan drugs.- Knowledge of drug development Scientific / Technical Excellence.- Experience in regulatory processes with Cofepris for a portfolio of innovative products: New Marketing Authorizations, variations & renewals

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