Regulatory Affairs Sr Mgr (GRAAS Biosimilars-CMC)

Thousand Oaks, CA, US
Nov 04, 2020
Required Education
High School or equivalent
Position Type
Full time
Amgen is a leading human therapeutics company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

This Group's purpose is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans; Coordinate global regulatory CMC activities relevant to the successful execution and implementation of biosimilar CMC regulatory strategies and plan; Develop CMC and analytical dossiers required for registration of biosimilar products; Manage long term CMC planning and regulatory CMC submissions for licensed products

Responsibilities of the position include:

Regulatory Filing and Strategy
  • Provide expertise in the development, communication, and implementation of global CMC regulatory strategies in support of Biosimilars Operating Unit's goals and product portfolio execution
  • Ensure regulatory documents (including analytical similarity packages and quality sections for briefing books, CTAs, MAs, annual reports, manufacturing amendments, and other documents as required) are developed with high quality and delivered in a timely manner
  • Lead cross-functional teams in development and submission of Quality documents, including responses to questions from regulatory authorities
  • Maintain product licenses per regulatory requirements and updated according to long-term plans
  • Support development and execution of clinical and non-clinical plans
  • Develop and deliver analytical similarity packages that meet biosimilar regulatory requirements, as directed by the RA CMC Lead
  • Deliver CMC information for submissions (including Module 3, analytical similarity assessments)
  • Prepare for and participate in CMC-related agency interactions
  • Represent RA CMC on the TOST and TOET
  • Provide CMC functional support for Amgen Biosimilars Operating Unit
  • Collaborate with other GRAAS functions on biosimilar issues, (eg, CMC, Regulatory Operations, Devices)
  • Comply with critical GRAAS CMC processes
    Regulatory Intelligence
  • Monitor, assess and implement regional CMC regulatory requirements
  • Review and assess CMC impact of health authority decisions for competitive products
  • Generate and communicate CMC intelligence to the Amgen Biosimilars Operating Unit
  • Participate in vendor oversight and management for regulatory CMC operations, as required
  • Provide regulatory risk assessment to the GRAAS Biosimilars function and to CMC filing teams
  • Identify process needs to meet internal challenges
  • Escalate CMC issues, progress, and metrics to the GRAAS Biosimilars function
  • Represent Biosimilars Regulatory Affairs CMC on committees, as necessary

Basic Qualifications:
  • Doctorate degree & 2 years of Regulatory and Compliance experience
  • Master's degree & 6 years of Regulatory and Compliance experience
  • Bachelor's degree & 8 years of Regulatory and Compliance experience
  • Associate's degree & 10 years of Regulatory and Compliance experience
  • High school diploma / GED & 12 years of Regulatory and Compliance experience

Preferred Qualifications:
  • Global regulatory CMC knowledge and experience
  • Regulatory submissions experience
  • Working with policies, procedures and SOPs
  • Biotech experience
  • Scientists with peripheral regulatory CMC experience, proven leadership
  • Product CMC lead, light stage and early stage programs, filing work, briefing docs, lead meetings
  • Industry experience in manufacture, testing (QC/QA), or distribution
  • Ability to understand and communicate scientific information
  • Ability to anticipate and prevent potential issues
  • Ability to communicate regulatory requirements to ensure expectations are understood
  • Experience in analytical similarity or comparability assessments and development of associated packages

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment, and inclusion in all that we do.

We will ensure that individuals with disabilities are provided 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 accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.