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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Regulatory Affairs Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans. The primary responsibilities of this role are to support the planning and execution of the site-specific aspects of the preparation of CMC sections for new marketing applications, and post-market supplements and preparation CMC sections of annual reports of minor changes for specific products, acts as key Regulatory Affairs (RA)-CMC representative for managing change control, deviations and serve as the point of contact for communications with business partners and global regulatory authorities for requests related to the site. Specific responsibilities include but are not limited to:

• Support the develop and implementation of regulatory strategies as they relate to changes at the site.
• Provide strategic expertise regarding regulatory requirements for manufacturing related projects.
• Coordinate activities with Global and International CMC representatives. 
• Interface with Regulatory Authorities as appropriate and in coordination with Global and International representatives.
• Support regulatory authority inspections as directed by Site Quality Compliance.
• Serve as RA - CMC representative on Cross Functional Teams.
• Lead or collaborate in the creation site related regulatory components for global submissions.
• Support the generation of facility and GMP related documents to be used in product registrations activities.
• Review and approve regulatory documents.
• Review and assess the regulatory impact of proposed manufacturing related changes, deviations and other GMP related documents.
• Maintain facility related files. 
• Develop and maintain regulatory awareness through meetings, conferences and regulatory contacts.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs Mgr professional we seek is a strong leader with these qualifications.

Doctorate degree OR

Master’s degree & 3 years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharmaceutical/Biotech industry

OR Bachelor’s degree & 5 years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharmaceutical/Biotech industry

Beyond that, additional preferred qualifications are:

• Educational background in Biology, Biotechnology, Microbiology or Chemistry
• Experience managing change control and regulatory submissions
• Strong oral and written communication skills in English and Spanish
• Strong negotiating and leadership skills
• Experience managing project timelines is desirable

• Proficiency working with teams at different levels and company locations
• Able to operate in a fast paced, dynamic environment

Thrive

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now ​for a career that defies imagination

Objects in your future are closer than they appear. Join us.