[Hiring] Regulatory Affairs Manager @Amgen

Role Description

Join Amgen’s Mission of Serving Patients. 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.

• 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

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

Requirements

• 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)

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible