Senior Associate Regulatory Affairs Fixed Term (2 years)

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. We have proudly achieved certifications as Great Place to Work and Equidad MX. Join us and transform the lives of patients while transforming your career.

Senior Associate Regulatory Affairs Fixed Term (2 years)

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What you will do

Keyresponsibilities 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 forLatAmwhere applicable.
• Prepare, review & approve of source text for LatAm 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).

Collaboration

• Collate, review, and distribute Regulatory information & intelligence with other regulatory colleagues and cross functional teams on an ongoing basis.
• Partner where required with International Regulatory Leads (IRLs), CMC and other functions to support the regulatory strategy, registration, timelines and lifecycle management of all Amgen molecules.
• Ability to work with different cross functional teams to share, discuss and negotiate the strategy and planning of submissions.

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 LatAm countries regulation relating to medicinal products and diverse portfolio of small molecules, innovative biotech’s, biosimilars and orphan drugs.
• Knowledge of drug development Scientific / Technical Excellence.
• Experience in regulatory processes with Health Authorityfor a portfolio of innovative products: New Marketing Authorizations, variations & renewals.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law