Regulatory CMC Lead – Biotech Strategy & Compliance

Amgen Inc.; United States; Remote; USD 113,000 - 153,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision

Disability insurance

Flexible spending accounts

Bonus program

Stock incentives

Generous PTO

Flexible work model

Job summary

Amgen, based in the United States, seeks a Regulatory Affairs Manager - CMC to lead site-specific regulatory strategies for post-market filings and registrations. You will coordinate with site functions to prepare regulatory filings, identify issues, and assess impacts on strategy with input from the CMC Product teams and regional representatives.

The role requires advanced degrees and substantial regulatory CMC experience; responsibilities include defining filing requirements, developing

Qualifications

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

Responsibilities

• 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

Skills

Regulatory affairs knowledge

CMC regulatory experience

Cross-functional collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

CTD structure knowledge

ICH guidelines knowledge

Job description

Amgen, based in the United States, seeks a Regulatory Affairs Manager - CMC to lead site-specific regulatory strategies for post-market filings and registrations. You will coordinate with site functions to prepare regulatory filings, identify issues, and assess impacts on strategy with input from the CMC Product teams and regional representatives.

The role requires advanced degrees and substantial regulatory CMC experience; responsibilities include defining filing requirements, developing