Senior Associate Regulatory Affairs

About the role

At Amgen, 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

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 CROs/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

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

Qualifications

• 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
• Ability to prioritize and balance multiple activities
• Ability to deal with ambiguity
• Ability to influence others

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