Regulatory Affairs Intelligence Sr Mgr

The Global Regulatory Policy & Intelligence (GRPI) group at Amgen engages with regulators, industry associations, and other stakeholders externally, and internally it manages regulatory intelligence for GRAAS monitoring, analyzing, and communicating regulatory requirements worldwide to enable fast, efficient global filings. The Senior Manager, as part of this team, plays a pivotal role in executing the regulatory intelligence function.

Key Responsibilities:

• Regulatory Intelligence Deliverables: Contribute to the monitoring and analysis of the global regulatory landscape and develop agreed intelligence deliverables under the supervision of the Regulatory Intelligence Director. This includes producing regulatory intelligence outputs that enable timely and efficient product filings worldwide for example, compiling summaries of country-specific regulatory requirements , analyzing recent or upcoming changes in regulations, and providing recommendations to teams on filing strategies that maximize speed and compliance. The Senior Manager is accountable for delivering these assigned intelligence outputs to a high standard of quality.

• Processes & Systems Ownership: Oversee the efficient operation of specific intelligence-gathering systems and processes . The Senior Manager may be responsible for maintaining and improving tools or databases used for monitoring regulations and for ensuring that intelligence monitoring, analysis, and communication processes run smoothly in their area of ownership. They work in partnership with colleagues across GRAAS to refine these systems and may evaluate opportunities for automation or outsourcing to improve efficiency.

• Regulatory Analysis & Strategy Input: Analyze regulatory trends across Amgens global footprint, identifying differences and commonalities in submission requirements between regions or product types. Based on this analysis, recommend practical approaches to dossier content and preparation that will satisfy local requirements while enabling globally efficient submissions. The Senior Manager provides this strategic input to global and local regulatory teams to influence filing strategies and ensure alignment with intelligence insights. They also identify major impending regulatory changes and help plan for regulatory change management efforts across the business (providing input to any large regulatory change projects).

• Cross-Functional Collaboration: Develop trusted relationships with cross-functional colleagues including Global and Local Regulatory Affairs teams, Regulatory CMC, Policy staff, and others to integrate intelligence into regulatory strategy and decision-making. The Senior Manager engages GRAAS policy staff, product strategy leads, and other experts to help establish priorities for intelligence activities and to execute on agreed deliverables. They often lead or coordinate cross-product regulatory projects (such as analyses to support multiple product filings) under the direction of the RI Director. In doing so, they ensure that intelligence findings are translated into actionable strategies and that any recommendations for policy advocacy (to promote global harmonization of requirements, for example) are communicated to the relevant teams.

• Continuous Improvement: Engage in continuous improvement of Regulatory Intelligence processes. The Senior Manager monitors progress against intelligence workplans and objectives, and conducts regular reviews with the RI Director to report on outcomes. They propose and implement enhancements to tools, methodologies, and workflows to increase the effectiveness of intelligence gathering and dissemination. For instance, they might help refine how regulatory information is captured and shared, contribute to templating requirements for future automation projects, or update procedures in response to lessons learned.

Knowledge & Skills:

• Regulatory Expertise: A strong foundation in regulatory affairs is required . The Senior Manager should have recent global filing experience and in-depth knowledge of regulatory agency guidelines and procedures across major and non-major markets. An understanding of local regulatory processes and how they impact global submissions is important. The role demands the ability to synthesize complex regulatory information (from disparate sources and regions) and distill it into clear, actionable insights and recommendations.

• Project Management & Communication: Excellent project management skills are needed to handle multiple intelligence projects and deliverables. The Senior Manager must be able to track tasks, meet deadlines, and coordinate input from various contributors. Strong presentation and interpersonal communication skills are essential in order to effectively communicate intelligence findings to stakeholders and to represent the intelligence function in cross-functional discussions. The ability to influence without direct authority (especially when recommending changes to regulatory strategy based on intelligence) is a key soft skill for this role.

• Technical and Process Skills: Preferred candidates will bring experience in systems management and process management , as the role involves working with databases/tools and improving processes for information gathering. Familiarity with knowledge management practices and change management principles is also beneficial for example, knowing how to systematically capture regulatory knowledge and support teams through major regulatory changes. An innovative mindset toward leveraging technology (including potential use of AI tools for intelligence) is a plus, given Amgens interest in future automation of submission-ready content.

Qualifications:

• Basic Qualifications: A combination of advanced education and relevant experience in life sciences/regulatory affairs. For instance, a Doctorate degree in a related field with ~4+ years of experience, Masters degree with ~3+ years, Bachelors degree with ~5+ years, Associates degree with ~10 years, or even a high school diploma/GED with ~12 years of directly related experience could be considered acceptable minimums. (These ranges align with internal job level guidelines for a role at the Senior Manager level.)

• Preferred Experience: Relevant industry experience in biopharmaceutical regulatory affairs (especially in regulatory intelligence, policy, or strategy functions) is highly desirable. The ideal candidate will have a track record of successfully managing regulatory information or contributing to regulatory submissions across multiple regions. Experience working on cross-functional teams and exposure to regulatory policy development or external advocacy would be a plus for this role.