Group Purpose
Global Regulatory Policy and Intelligence engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important Regulatory policy issues aligned with Amgen’s goals and priorities. Regulatory Intelligence for the GRAAS organization enables fast, efficient global filings by effectively monitoring, analyzing, and communicating regulatory requirements to regulatory strategy leads and others involved in the delivery of regulatory submissions and approvals. Coordination of change management activities in response to major changes in regulation also falls within the remit of this organization.
Job Summary
Performs monitoring and analysis of the global regulatory landscape according to defined plans and priorities and delivers agreed regulatory intelligence outputs. The Technology Systems Manager will be responsible for creating, developing, and maintaining a comprehensive databases and systems to facilitate optimizing data resource platforms and systems to collect and disseminate relevant regulatory information to internal stakeholders, ensuring timely awareness and compliance. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs and intelligence.
Key Activities
Facilitates and supports the tools and platforms utilized to prepare regulatory intelligence outputs that guide the successful development, submission and approval of Amgen products worldwide.
Uses internal and external contacts, tools and systems to gather regulatory intelligence
Applies professional skills and experience with advanced tools to summarize and contextualize regulatory intelligence information and identify trends in agency feedback
Effectively communicates regulatory requirements to Regulatory Affairs staff
Continually seeks opportunities to improve the usefulness of regulatory intelligence outputs and the effectiveness of tools and systems.
Works with limited supervision according to predefined regulatory intelligence workplans
Applies tools and systems to deliver agreed intelligence objectives
Communicates progress and escalates issues impacting delivery of intelligence outputs
Provides suggestions for improvement of processes, systems and tools employed within the function.
Knowledge and Skills
Basic:
Regulatory intelligence monitoring, analyzing, and interpreting global regulatory developments to ensure compliance and inform strategic decision-making.
Knowledge of regulatory agency guidelines and procedures (major and non-major markets)
Knowledge of regulatory intelligence systems and platforms
Understanding and application of aspects of global and local regulatory process
Project management skills
Presentation and interpersonal communication skills
Preferred:
Global Regulatory Intelligence monitoring experience
Education and Experience (basic)
Doctorate degree, OR
Master’s degree and 3 years of directly related experience. OR
Bachelor’s degree and 5 years of directly related experience, OR
Associate’s degree and 10 years of directly related experience
Education and Experience (preferred)
A bachelor's degree in life sciences or a related field; advanced degrees may be preferred.
A minimum of 5 years of experience in regulatory affairs, with at least 3 years in a regulatory intelligence role within the pharmaceutical, biotechnology, or medical device industries.
In-depth knowledge of global regulatory frameworks and guidelines, such as those from the FDA, EMA, and other health authorities.
Strong analytical and problem-solving skills, with the ability to interpret complex regulatory information and provide actionable insights.
Excellent communication skills, both written and verbal, to effectively present information to diverse audiences.
Proficiency with regulatory intelligence databases and software tools.