Senior Regulatory Affairs Associate: Submissions Lead

Regulatory Jobs; United States; Remote; USD 84,000 - 114,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models where possible

Job summary

Amgen seeks a Senior Associate in Regulatory Affairs to ensure products meet regulatory standards and support submissions to agencies. You will prepare regulatory packages, maintain history via RIM, and coordinate with Global/Regional leads.

Qualifications include advanced degrees with Regulatory Affairs experience and ability to support GRSP deliverables; salary range reflects U.S. market norms for this role.

Qualifications

• 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.
• Bachelor’s degree in Life Sciences and 2-3 years of Regulatory Affairs experience.
• Experience setting up regulatory submissions.

Responsibilities

• Assist Regional Regulatory Lead to support regional regulatory activities
• Provide and maintain IND/MA documentation support in collaboration with Regional Regulatory Lead
• Create and maintain product regulatory history documents through RIM
• Review regional component of the Global Regulatory Strategic Plan and provide input to operational deliverables
• Actively support regulatory compliance and ensure submissions to regulatory agencies
• Assist the Global or Regional Regulatory Lead by preparing supportive documentation for regulatory deliverables
• Coordinate collection of functional documents in support of regulatory applications
• Participate in GRT and assist in meeting management to advance regulatory knowledge
• Assist in responding to regulatory agency questions
• Coordinate QC of regulatory documentation
• Provide primary authorship to routine regulatory correspondence
• Prepare regulatory packages and cross-reference letters to support investigator initiated studies
• Complete regulatory forms to support agency communications
• 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
• Support the development and execution of GRT goals

Education

Master’s degree

Bachelor’s degree with 2 years Regulatory Affairs experience

Associate’s degree with 6 years Regulatory Affairs experience

High school diploma / GED with 8 years Regulatory Affairs experience

Job description

Amgen seeks a Senior Associate in Regulatory Affairs to ensure products meet regulatory standards and support submissions to agencies. You will prepare regulatory packages, maintain history via RIM, and coordinate with Global/Regional leads.

Qualifications include advanced degrees with Regulatory Affairs experience and ability to support GRSP deliverables; salary range reflects U.S. market norms for this role.