Regulatory Affairs Manager - CMC

Regulatory Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year.

As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team.

Join us and transform the lives of patients while transforming your career.

Let’s do this. Let’s change the world. In this vital role you will be responsible for the strategy and execution of the site-specific aspects of the preparation of CMC post-market supplements and facility registrations. You will interface with site functions to coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity and provide impact assessments for deviation with input from the CMC Product teams and the CMC Region representative.

You will serve as Regulatory CMC voice for product teams by providing the following services:

• Define minimum regulatory filing requirements for post approval programs
• Provide regulatory strategy through development of MASP and/or GIRS
• Development of post approval variations
• Maintenance of applications (Annual Reports, Distribution Reports, Annual Stability updates)
• Maintain product compliance through appropriate regulatory filings and activities including regulatory commitments
• Provide impact assessments for deviation with input from the CMC Product teams and the CMC Region representative
• Support Change Management activities as needed
• Respond to regulatory agency questions
• Facilitate agency interactions, including meeting preparation, meetings and briefing documents
• Liaise with other Functions in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution and plans
• Contribute to the PDT’s Variation Master Plan as required
• Participate as an active member of cross-functional teams

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

• Doctorate degree
• OR
• Master’s degree and 2 years of Regulatory Affairs experience
• OR
• Bachelor’s degree and 4 years of Regulatory Affairs experience
• OR
• Associate’s degree and 8 years of Regulatory Affairs experience
• OR
• High school diploma / GED and 10 years of Regulatory Affairs experience

• Degree in a life sciences discipline, or equivalent relevant experience.
• Experience in Regulatory CMC within the pharmaceutical or biotechnology industry.
• Working knowledge of ICH guidelines and current GMP and GCP requirements.
• Experience preparing and compiling regulatory dossiers in accordance with ICH guidelines and Common Technical Document (CTD) structure.
• Experience in pharmaceutical or biotechnology manufacturing, Quality Control (QC), or Quality Assurance (QA).

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our…