Regulatory Affairs Sr Manager

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youre 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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; and Maintain a knowledge base of current and emerging CMC regulatory environments, guidelines and best practices, and interpret and communicate relevant issues to colleagues. May telecommute.

Masters 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. Experience also requires 6 years in the following:

Leading interactions with Regulatory Agencies including the preparation of briefing documents and the coordination of meeting logistics;
Organizing, preparing, or reviewing Chemistry, Manufacturing and Controls (CMC) content for clinical trial applications or marketing applications for submissions to health authorities;
Compiling Chemistry, Manufacturing and Controls quality data utilizing Veeva Vault quality and regulatory information management system;
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; and Analyze, summarize, and interpret scientific data with understanding of the applicable limitations of the data.

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Job type:
Full Time position. The annual salary for this position in the U.S. is $ per…