Regulatory Affairs Senior Associate - Remote

Overview

The Regulatory Affairs Sr Associate will facilitate product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout the product lifecycle.

In Short

• Track license status to ensure all are current and effective.
• Communicate requirements to internal functional teams.
• Obtain supplemental documentation from internal and external partners.
• Prepare, review, and submit license applications and renewals.
• Maintain all State Licensing documentation and interactions with State Authorities.
• Interface with State Board of Pharmacy and/or Department of Health.
• Complete required annual notifications to FDA.
• Collaborate with Global CMC, Site CMC, and Device Regulatory teams.
• Support regulatory compliance for Amgen products across development phases.
• Engage in maintaining U.S. state and federal commercial product licenses.

Requirements

• Master’s degree OR Bachelor’s degree with 2 years of relevant experience.
• Associate’s degree with 6 years of relevant experience is also acceptable.
• Degree in Life Science discipline preferred.
• Regulatory CMC specific knowledge & experience.
• Experience in manufacture, testing, or distribution in Pharmaceutical/Biotech industry.
• Working knowledge of US state and federal licensing requirements.

Benefits

• Competitive and comprehensive Total Rewards Plans.
• Collaborative culture that supports professional growth.
• Commitment to improving quality of life for patients.
• Inclusive environment for diverse and ethical individuals.
• Opportunities to unlock the potential of biology for patients.
• Support for reasonable accommodation for individuals with disabilities.