Associate – Regulatory Affairs

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.
Ensure Regulatory submissions are made on time and meet Amgen’s corporate and local Regulatory requirements.
Contribute to and implement filing plans, where applicable.
Review source text for country labelling.
Disseminate relevant information to team(s) as appropriate.
Participate in local Regulatory process improvement initiatives.
Assist locally in Healthcare Compliance activities, where applicable.
Collate, distribute, exchange, and review 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.
Review translations for local Regulatory submissions.
Partner with International Regulatory Leads (IRLs) to support the Regulatory development, registration, and lifecycle management of all Amgen molecules.
Health Authority Interactions.
Under general supervision, interact with local health and Regulatory authorities for routine matters.

1+ year of Regulatory affairs experience
Regulatory Certificate
Knowledge of Regulatory principles
Working with policies, procedures and SOP’s
Knowledge of national legislation and regulations relating to medicinal products
Awareness of the registration procedures in Canada for clinical trial applications, marketing applications, post-approval changes and extensions
Knowledge of drug development
Scientific / Technical excellence
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues
Understanding of Regulatory activities and their touch points
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Cultural awareness and sensitivity to achieve results across both regional country and International borders