Regulatory Affairs Sr Mgr (GRAAS Biosimilars-CMC)

Regulatory Affairs Sr Mgr (GRAAS Biosimilars-CMC)

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.

- Coordination of global regulatory CMC activities relevant to the successful execution and implementation of biosimilar CMC regulatory strategies and plans
- Development of CMC and analytical dossiers required for registration of biosimilar products
- Management of long term CMC planning and regulatory CMC submissions for licensed products

Key Activities:
Regulatory Strategy and Filing
- 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
Collaboration
- 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 directly related experience
OR
- Master's degree & 6 years of directly related experience
OR
- Bachelor's degree & 8 years of directly related experience
OR
- Associate's degree & 10 years of directly related experience
OR
- High school diploma / GED & 12 years of directly related experience

Preferred Qualifications
- CMC-specific regulatory knowledge and experience
- Ability to understand and communicate scientific information
- Ability to anticipate and prevent potential issues
- Ability to communicate regulatory requirements to ensure expectations are understood
- Industry experience in manufacture, testing (QC/QA), or distribution
- Global regulatory CMC knowledge and experience
- Regulatory submissions experience
- Working with policies, procedures and SOPs
- Experience in analytical similarity or comparability assessments and development of associated packages