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 International Regulatory Leads (IRLs) 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.
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