Associate Regulatory Affairs
One Amgen Center Drive Thousand Oaks, California 91320 | Contract
• Local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Management and 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 company’ 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
• Maintain an awareness of & ensure local management are kept up to date on new & developing local legislation & regulatory policy
• Disseminate relevant information to team(s) as appropriate
• Participate in local regulatory process improvements initiatives
• Assist locally in Healthcare Compliance activities where applicable
• Coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies.
• 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.
• 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 company molecules.
• Under general supervision participates in regulatory activities to ensure effective local agency interactions
• Act as a contact where appropriate with regulatory agencies in fulfilling local obligations by product assignment
- Scientific background in pharmaceutical, biotech, health, chemistry or related sciences
- Document management and archiving practices (with high attention to details)
- Ability to understand and communicate scientific/clinical information
- Spanish Bilingual Preferred