Amgen
Senior Associate - Regulatory Affairs
United States - Remote · Senior
Sponsorship not specifiedDetected 6 hours ago
ComplianceProcess ImprovementFDA RegulatoryResearchCommunicationCollaborationOrganizational SkillsRegulatory Affairs
About the role
- 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.
Responsibilities
- Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications
- 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
- Prepare regulatory packages and cross-reference letters to support investigator initiated studies
- Support process improvement initiatives, standards development, and metricsDescription
- In this vital role you will 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.
- Develop Regulatory Position with teams
- Actively support regulatory compliance
Requirements
- 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 have
- Regulated industry, science or clinical practice experience
- Timeline management
- Strong communication skills - oral and written
- Organizational skills
- Agendas, minutes
- Award-winning time-off plans
- What you can expect of us
- careers.amgen.com
Compensation
- 83,974.90USD -113,613.10 USD
- 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
- Coordinate QC of regulatory documentation (e.g. briefing packages)Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Benefits
- Complete regulatory forms to support agency communicationsProvide regulatory support to Commercial, Medical and Clinical departments through crossfunctionalinteractions in brand and therapeutic area teams
Company info
- We are all different, yet we all use our unique contributions to serve patients.
Equal opportunity
- Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
- Please contact us to request accommodation.
- We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.