Regulatory Affairs Associate

4 days ago

Hong Kong Island, Hong Kong SAR China Amgen SA Full time

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Regulatory Affairs Associate (12-months contract) in Hong Kong.

Live

What you will do

Responsibilities

Execution

  • Ensures regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements.

  • Creates and reviews source text for country labeling.

  • Reviews promotional and non-promotional materials.

  • Coordinates translation for local Regulatory submission.

  • Participates in the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements, as needed.

Communication and Collaboration

  • Exchanges 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.

  • Partners with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.

  • Partners with peers to ensure consistency on procedures.

Country Specific Activities

  • Assists locally in Healthcare Compliance activities, where applicable.

  • Participates in local regulatory process improvements, initiatives, and training.

  • Oversees external vendor/contractor relationships, where applicable.

Win

What we expect of you

Minimum Requirements

  • Bachelor's degree (scientific area)

  • Good communication skills in English and Chinese (both oral and written)

Preferred Requirements

  • Regulatory experience in the applicable country(ies).

  • Knowledge of country(ies) legislation and regulations relating to medicinal products.

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 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.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, 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.

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