Sr Associate Regulatory Affairs

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.

You will have the opportunity to devise, develop and implement creative regulatory strategies to bring novel products to patients as quickly and efficiently as possible - and to craft the regulatory framework in which we operate.

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more expert regulatory lead.
- Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
- Chip in to and implement the filing plan for Colombian Regulatory Authorities.
- Review source text for country labeling.
- Review promotion and non-promotion materials.
- Maintain an awareness of & ensure local management are kept up to date on new & developing local legislation & regulatory policy.
- Disseminate relevant information to team(s) as appropriate.
- Participate in local regulatory process improvements initiatives.
- Assist locally in Healthcare Compliance activities where applicable.
- Coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies.
- 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.
- Coordinating translation for local Regulatory submission.

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The collaborator we seek is a Regulatory Affairs professional with these qualifications.

Basic Qualifications:

- Proven experience working within the Pharmaceutical or Biotechnology Industry within the Regulatory Affairs Area.
- Experience reviewing and compiling product dossiers, risk assessment and dossier submission.
- Deep understanding of Colombian Regulatory environment.
- Excellent Communication skills, both in English and Spanish.
- Working knowledge of IT Systems relevant to the role (Veeva, Lexa, etc)
- Keen Collaboration and partnership promoter.

Thrive

What you can expect of us

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.
- Vast opportunities to learn and move up and across our global organization
- 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

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, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.