Senior Associate Regulatory Affairs

Career Category

Regulatory

**Job Description**:
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 Senior Associate Regulatory Affairs in Singapore

Senior Associate Regulatory Affairs

Live

What you will do

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen is searching for a Senior Associate for the Regulatory Optimization of Tactical and Strategic Support (ROOTS2) group within RA CMC. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries.

The RA CMC Senior Associate will collaborate with the Amgen global, international, site and biosimilars RA CMC teams and the device team for specific strategies or activities that impact a product. The RA CMC Senior Associate will be responsible for varying levels of product support, including leading projects, based upon their experience level.

Additional job responsibilities of the RA CMC Senior Associate include:

- Contribute as a key member of the global regulatory CMC product team
- Lead the organization and preparation of the CMC sections of global annual notifications to meet regulatory requirements
- Document and archive CMC submissions and related communications in the document management system
- Initiate and maintain CMC product timelines at the direction of product lead
- Work with the regulatory operations team
- Train staff on select CMC procedures and systems
- Provide report status of activities and projects to teams and department
- Participate in cross-functional special project teams

Win

What we expect of you

**Qualifications**:

- Master’s degree
- OR
- Bachelor’s degree and 2 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience
- OR
- High school diploma and 8 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience

Preferred Qualifications:

- BS degree in Life Science
- Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
- Regulatory CMC specific knowledge and experience
- Mature project management and organizational skills
- Strong and effective oral and written communication skills

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. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards._

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.

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.

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