Senior Associate - Regulatory Affairs
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. 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. 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
- Bachelor’s degree and 2 years of Regulatory Affairs experience
- Associate’s degree and 6 years of Regulatory Affairs experience
- High school diploma / GED and 8 years of Regulatory Affairs experience
Nice To Haves
- Master’s degree in a biology, life science, health science curriculum, or regulatory sciencewith biology curriculum
- Regulated industry, science or clinical practice experience
- Timeline management
- Strong communication skills - oral and written
- Organizational skills
- Ad hoc meeting support
- Agendas, minutes
Responsibilities
- Assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.
- Assist U.S. Regulatory Lead to support regional regulatory activities.
- Provide and maintain IND/BLA documentation support (e.g. annual reports, amendments) in collaboration with U.S. Regulatory Lead
- Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications
- Review regional component of the Global Regulatory Plan and provide input to operational deliverables
- Ensure compliance with submissions to regulatory agencies
- Support U.S. Regulatory Lead in review of HA interaction activities
- Collaborate with CRO’s / partners to support site initiation, as applicable
- Coordinate collection of functional documents in support of regulatory applications
- As appropriate participate in GRT to support execution of regulatory strategy
- Coordinate QC of regulatory documentation (e.g. briefing packages)
- Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
- Prepare regulatory packages and cross-reference letters to support investigator initiated studies
- Approve drug shipment for Amgen and Investigator Initiated Studies
- Complete regulatory forms to support agency communications
- Provide regulatory support to Commercial, Medical and Clinical departments through crossfunctionalinteractions in brand and therapeutic area teams
- Support process improvement initiatives, standards development, and metrics
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to GRT
- Develop Regulatory Position with teams
- Actively support regulatory compliance
- Support the development and execution of GRT goals
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
