Regulatory affairs manager| ELI & South Africa

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

• If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Regulatory Affairs Manager ELI & ZA

Job Responsibilities:

• High-quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA) and line-extensions.
• Maintain established products according to global and local regulatory plans.
• Update and maintain regulatory databases.
• Handle Health Authorities requests.
• Build and keep a highly professional relationship with the Medicines Agency.
• Support and interact with global regulatory affairs QA Market Access Marketing (projects and product teams) and Sales to best support local and global strategy.
• Monitor future trends in regulatory affairs which are likely to affect AMGEN interest.
• Perform or facilitate audits to ensure compliance

Qualifications:

• A bachelors degree in Pharmacy or any relevant field.
• Minimum of 6 years of regulatory experience in the pharmaceutical industry or with Health Authorities.
• Excellent current regulatory knowledge understanding of US FDA and EMEA regulatory guidelines.
• Advanced ability to interpret scientific data and to construct persuasive regulatory documents.
• Good communication skills ability to work effectively in a matrix setup.
• Strong knowledge of regulatory life cycle maintenance.
• Having People Management experience is critical.
• An analytical approach balanced with a keen eye for detail demonstrated in all document control and administration undertaken.
• Strong communication and leadership skills with the ability to select motivate train and develop staff to achieve company goals.

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 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

Apply now 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 gender sexual orientation gender identity national origin protected veteran status or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation.