Associate Regulatory Affairs

Career Category

Regulatory

**Job Description**:
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.

Associate Regulatory Affairs

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible of:
Strategic and Execution
- Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
- Contribute to and implement, execute the filing plan for their country where applicable.
- Review & approval of source text for country labeling, and owners of country artwork based on source text.
- Review and approval of promotion and non-promotion materials.

Regional Specific Activities
- Assist locally in Healthcare Compliance activities where applicable.
- Input into the affiliate / local office compliance framework to ensure complies with local codes and legislation and Amgen policies.
- Disseminate relevant information to team as appropriate.
- Participate in local regulatory process improvements initiatives and training.
- Where applicable oversee external vendor/contractor relationships.

Collaboration
- Collaborating with Global Study Operations (GSO) to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate)
- Exchange regulatory information & intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
- Partner where required with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seek would have acquired the knowledge and skills vital to perform the duties of this position through the following combination of education, experience and knowledge or the equivalent.

Preferred Requirements
- University Degree (QF's and industrial engineers)
- Systems management approach
- Working with policies, procedures and SOP’s
- Knowledge of national legislation and regulations relating to clinical development
- Awareness of the registration procedures in region for clinical trial sand amendments. Import license process for medical supplies
- Knowledge of drug development/ Regulatory principles.
- Team work.
- Communication skills - both oral and written.
- Ability to anticipate and prevent potential issues.
- Understanding of regulatory activities and their touch points.
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.

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

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

Amgen does not discriminate in its employment opportunities on the basis of sex, race, color, age, national origin, political or religious ideas, gender, sexual orientation, gender identity, level and type of disability, ethnic origin, or any other category protected by law.

.