Senior Associate - Regulatory Affairs (US-Remote)

Role Summary

Senior Associate - Regulatory Affairs. In this role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.

Responsibilities

• 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
• 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

Qualifications

• Required: Master’s degree
• Required: Bachelor’s degree and 2 years of Regulatory Affairs experience
• Required: Associate’s degree and 6 years of Regulatory Affairs experience
• Required: High school diploma / GED and 8 years of Regulatory Affairs experience
• Preferred: Strong communication skills - both oral and written
• Preferred: Ability to understand and communicate scientific/clinical information
• Preferred: Ability to collaborate with team members to tackle problems and develop a course of action
• Preferred: Cultural awareness and sensitivity to achieve global results
• Preferred: Planning and organizing abilities
• Preferred: Able to prioritize and balance multiple activities
• Preferred: Ability to deal with ambiguity
• Preferred: Ability to influence others

Skills

• Strong communication (oral and written)
• Ability to understand and communicate scientific/clinical information
• Collaboration and problem-solving
• Cultural awareness for global results
• Planning, organizing, prioritization
• Ability to work with ambiguity and influence others

Education

• Details aligned with Basic Qualifications above