Job Description

Career CategoryRegulatory

Regional Specific Activities . Ensure 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 . Review source text for country labeling . Review promotion and non-promotion materials . Disseminate relevant information to team(s) as appropriate . Participate in local regulatory process improvements initiatives . Assist locally in Healthcare Compliance activities where applicable . 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 . Coordinating translation for local Regulatory submission.

Collaboration . Collate, distribute and review Regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis. . Partner where required with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.

HA Interaction . Under general supervision interact with local health and regulatory authorities for routine matters Knowledge and Skills . 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 region for MA, post approval changes, extensions and renewals. . Knowledge of drug development

Scientific / Technical Excellence . Team work . Communication skills - both oral and written . Ability to understand and communicate scientific/clinical information . Ability to anticipate and prevent potential issues . Knowledge of and experience in regional regulatory environment in relevant product area and development stage . 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. Bachelor's degree in Pharmaceutical and 2 years of directly related experience

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R-185946