Senior Associate - Regulatory Affairs (US-Remote)

Amgen • Thousand Oaks, CA

9d • Remote

About The Position

HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Senior Associate - Regulatory Affairs Live What you will do Let’s do this. Let’s change the world. In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements. To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions To assist the Global Regulatory Lead to manage GRT interactions

Requirements

• Master’s degree Or Bachelor’s degree and 2 years of Regulatory Affairs experience Or Associate’s degree and 6 years of Regulatory Affairs experience Or High school diploma / GED and 8 years of Regulatory Affairs experience

Nice To Haves

• Strong communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to collaborate with team members to tackle problems and develop a course of action
• Cultural awareness and sensitivity to achieve global results
• Planning and organizing abilities
• Able to prioritize and balance multiple activities
• Ability to deal with ambiguity
• Ability to influence others

Responsibilities

• Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
• Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
• Create and maintain product regulatory information and history documents through Amgen systems
• Appropriately archive regulatory documents and agency communications
• Collaborate with CRO’s / partners to support site initiation
• Complete regulatory forms to support agency communications
• Participate in GRT to support execution of regulatory strategy
• Coordinate QC of regulatory documentation (e.g. briefing materials)
• Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
• Assist in template development and maintenance
• Respond to specific requests from and communicate relevant issues to GRT
• Actively support regulatory compliance

Benefits

• 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, we’ll support your journey every step of the way.
• 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, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees