CW-Regulatory Affairs Associate/Senior Associate

Career Category

Job Description

Job Summary

• Local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Execution of the preparation, delivery and electronic archiving of documentation for inclusion in local regulatory submissions.
• Coordination and execution of Regulatory Affairs processes and deliverables in the local office.

Responsibility:

• Ensures regulatory submissions are made on time and meet company’s corporate and local regulatory requirements.
• Creates and reviews source text for country labeling.
• Reviews promotional and non-promotional materials.
• Coordinates translation for local Regulatory submission,
• Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.
• Partners with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all company molecules.
• Partners with peers to ensure consistency on procedures
• Assists locally in Healthcare Compliance activities, where applicable.
• Participates in local regulatory process improvements, initiatives and training.
• Oversees external vendor/contractor relationships, where applicable.

Requirements:

• Bachelor’s degree in scientific area or related
• Knowledge of Regulatory principles.
• Working with policies, procedures and SOP’s.
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• Understanding of drug development.
• Demonstrate ability to work in teams.
• Ability to understand and communicate scientific/clinical information

Leading biotechnology company focused on oncology, cardiovascular, bone health, and inflammation therapies. Based in Thousand Oaks, CA.

amgen.com