Regulatory Affairs Manager

Career Category

Job Description

The Regulatory Affairs Manager at Amgen ensures the companys compliance with all regulations and laws pertaining to the companys business. They work with federal state and local regulatory agencies on issues and regulations that affect the companys products and services.

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 read over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

REGULATORY AFFAIRS MANAGER CMC (CHEMISTRY MANUFACTURING AND CONTROLS)

LIVE

What you will do

The RA CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site. The CMC site team interfaces with the site (R&D and operations authors) coordinates preparation of regulatory filings identifies issues and factors that may impact a regulatory strategy or activity. The CMC site team are members of CMC product teams. The CMC Site team is also responsible for confirmation on change control regulatory assessments with input from the CMC Product teams and the CMC Region representative. The CMC site team is the key RA CMC representative on product deviation investigation teams.

• Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements submission strategy and regulatory risk assessments
• Support development of global dossiers for CMC content of new marking applications (MAA) new clinical trials (CTA) variations and amendments to existing MAA/ CTAs.
• Development of post-approval submissions including maintenance of applications
• Support Change Management activities
• Respond to regulatory agency questions
• Liaise with the Global RA CMC product lead ROOTS representatives and other functions in development operations and commercial to ensure alignment of global regulatory strategies and timing execution
• Monitor and as necessary provide data to be entered into tracking systems for department deliverables and ensure information is current
• Participate as an active member of cross-functional teams

Be part of our team

You will be joining the Regulatory Affairs Site CMC team under the RA CMC Department. We are a global team with remote team members across the US Ireland Breda and Puerto Rico. This RA CMC team is part of the Global Regulatory Affairs and Strategy (GRAAS) organization under the Amgen Research and Development Division.

We all work together to serve every patient every time by meeting the demands of an industry-leading fast paced organization. We keep a commitment to innovation and quality in all that we do; whilst delivering sound RA CMC strategies and submission documents for maintaining the compliance of current Marketing Applications related to Amgens synthetics molecule portfolio.

WIN

What we expect of you

We are all different yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills:

Basic Qualifications:

• Doctorate Degree Or
• Masters Degree and 3 years of Regulatory CMC or related technical experience Or
• Bachelors Degree and 5 years of Regulatory CMC or related technical experience Or
• Associates degree and 10 years of Regulatory CMC or related technical experience

Preferred Qualifications:

• Degree in Life Science
• Regulatory CMC knowledge and experience with small molecule and/or Biologic products
• Experience in manufacture testing (QC/QA or clinical) process development or other related Pharmaceutical/Biotech industry

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

Objects in your future are closer than they appear. 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.

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.