Senior 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 read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

**SENIOR ASSOCIATE REGULATORY AFFAIRS**

**LIVE**

**What you will do**

In this role you will support marketed products and investigational in vitro diagnostic medical devices to be used in combined trials under the supervision of an experienced Local Regulatory Lead.

The key responsibilities will be:

- Assist in aligning local regulatory requirements with Amgen’s corporate standards.
- Provide national input to and execute regulatory strategies.
- Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
- Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
- Enable regulatory agencies interactions.
- Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for IVD performance studies in accordance with national regulatory requirements.
- Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
- Create, review, and approve source text for country labeling, and own the country artwork based on source text.
- Act as the point of contact with regulatory agencies in fulfilling local obligations.
- Participate/contribute to local agency interactions and their preparation.
- Work closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.
- Exchange regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.
- Participate in local regulatory process improvements, initiatives, and training.

**WIN**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
**Qualifications**:

- Degree in Pharmacy, Biochemistry, Biotechnology, Biology or related field
- Master’s degree on Pharmaceutical Industry desirable
- Fluency in Spanish and English languages. Knowledge on Portuguese language is desired.
- Depth knowledge of legislation and regulations relating to medicinal products and in vitro diagnostic medical devices.
- 2 or more years of relevant work experience within the pharmaceutical industry

**Skills**:

- Ability to work in teams
- Attention to detail
- Priorization skills
- Solution oriented problem-solving skills

**THRIVE**

**What you can expect of us**

As we work to develop treatments that take care of others, so we 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 colleagues 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

**Equal Opportunity statement**

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.