Amgen Sr Associate Regulatory Affairs in Mexico City, Mexico
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. 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.
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.
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
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.