Career Category

Job Description

Title (Role)

Local Regulatory Representative (LRR), Associate

Organization

Regional Regulatory Affairs

Team

Local Regulatory

Group Purpose

Local Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.

Job Summary

The Local Regulatory Representative (Associate) is assigned to one or more Amgen products and could support another LRR. The Local Regulatory Representative (LRR) Associate under the direction of a Local Regulatory Representative (LRR) Sr. Manager or Manager performs:

• 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.

Key Activities

EXECUTION

• Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
• Contribute to and execute the filing plan for their country where applicable
• Creates and reviews source text for country labeling.
• Coordinates translation for local Regulatory submission.
• Disseminate relevant information to team(s) as appropriate
• Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner

COMMUNICATION AND COLLABORATION

• 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 Amgen molecules.
• Partners with peers to ensure consistency on procedures.

 COUNTRY SPECIFIC ACTIVITIES

• Assists locally in Healthcare Compliance activities, where applicable.
• Participates in local regulatory process improvements, initiatives and training.
• Oversees external vendor/contractor relationships, where applicable.

Knowledge and Skills

Scientific and Technical

• 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.

HA Interaction

• Under general supervision interact with local health and regulatory authorities for routine matters

Others

• Demonstrate ability to work in teams.
• Ability to understand and communicate scientific/clinical information.
• Education & Experience (Basic)
• Bachelor’s degree (scientific area)
• Education & Experience (Preferred)
• Degree and in-depth regulatory experience and/or related to the country(ies).
• Depth knowledge of regional country(ies) legislation and regulations relating to medicinal products.
• Good command of spoken and written English.
• Preferred at least 1 year of RA experience

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.