Regulatory Affairs Sr Manager

Amgen•Deerfield, IL

8d•Remote

About The Position

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.

Requirements

Master’s degree (or foreign equivalent) in Regulatory Science, Environmental, Safety and Health management or a related field & 6 years of experience in the job offered or in an Associate or regulatory- related occupation.
6 years of experience leading interactions with Regulatory Agencies including the preparation of briefing documents and the coordination of meeting logistics
6 years of experience organizing, preparing, or reviewing Chemistry, Manufacturing and Controls (CMC) content for clinical trial applications or marketing applications for submissions to health authorities
6 years of experience compiling Chemistry, Manufacturing and Controls quality data utilizing Veeva Vault quality and regulatory information management system
6 years of experience in development and management of project timelines and deliverables
Knowledge of International regulatory standards concerning drug development including Good Laboratory Practices, Good Clinical Practices, or Good Manufacturing Practices
Knowledge of the Food and Drug Administration organization, roles, and responsibilities concerning drug development
Analyze, summarize, and interpret scientific data with understanding of the applicable limitations of the data

Responsibilities

Formulate and present CMC regulatory strategies, ensuring alignment with corporate objectives, in conjunction with Technical Operations, R&D, Commercial and other internal stakeholders, as needed, across investigational and marketed products
Develop risk register for all major regulatory submissions outlining potential regulatory risks and proposals for mitigation strategies
Coordinate and collaborate on the preparation of CMC components of regulatory submissions
Provide guidance for and contribute actively to the development of CMC related documents for regulatory submissions, Health Authority Meetings Requests, and Briefing Books, ensuring that they meet current regulatory standards including guidance and expectations are high quality consistent, complete and approvable on the first review cycle
Develop strategies for and collaborate on preparation of responses to CMC-related topics with health authorities
Review manufacturing/testing change controls and provide regulatory impact assessments
Responsible for representing and supporting CMC regulatory on multidisciplinary project teams and providing CMC regulatory guidance
Ensure compliance with Health Authority expectations and regulatory guidance
Maintain a knowledge base of current and emerging CMC regulatory environments, guidelines and best practices, and interpret and communicate relevant issues to colleagues

Benefits

stock
retirement
medical
life and disability insurance
eligibility for an annual bonus
health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
flexible spending accounts
discretionary annual bonus program
sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible