Regulatory Affairs Intelligence Mgr

Career Category Regulatory Join Amgen s Mission of Serving Patients At Amgen if you feel like you re part of something bigger it s because you are Our shared mission to serve patients living with serious illnesses drives all that we do Since 1980 we ve helped pioneer the world of biotech in our fight against the world s toughest diseases With our focus on four therapeutic areas -Oncology Inflammation General Medicine and Rare Disease- we reach millions of patients each year As a member of the Amgen team you ll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives Our award-winning culture is collaborative innovative and science based If you have a passion for challenges and the opportunities that lay within them you ll thrive as part of the Amgen team Join us and transform the lives of patients while transforming your career Manager Global Regulatory Intelligence The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director This role often has a technology and data focus managing the tools and information that drive the intelligence process Key Responsibilities Intelligence Gathering Analysis Assist in monitoring and analyzing the global regulatory landscape and in developing intelligence reports and updates as directed by the RI Director A core duty is to collect and synthesize new or updated local regulatory requirements obtained from Amgen s local regulatory teams for the Manager s assigned areas of responsibility This information feeds into the group s centralized knowledge base The Manager helps execute the regulatory intelligence workplans by preparing agreed deliverables - for example compiling monitoring reports bulletins and landscape summaries that highlight regulatory changes or requirements relevant to upcoming filings They ensure that these deliverables are coherent and actionable providing clear recommendations or insights where appropriate Tools Data Management Take ownership of the tools databases and documentation that support intelligence gathering and dissemination The Manager is responsible for facilitating and maintaining these systems on a day-to-day basis This includes ensuring that repositories of regulatory requirements and intelligence reports are up-to-date and accessible to stakeholders Importantly the Manager may also be expected to build or modify new tools and databases as needed not just use existing ones For example if a new tracking database or dashboard is required to capture regulatory changes the Manager would play a key role in its development or configuration Emphasizing this in the job description sets clear expectations that the role involves technical initiative in improving intelligence systems Cross-Functional Support Work closely with other members of the Regulatory Policy Intelligence team and with regulatory staff in various functions to ensure intelligence is applied effectively The Manager engages with policy analysts product regulatory leads and other cross-functional team members to share findings and gather input While the Manager may not lead cross-functional projects independently they support these efforts by providing the necessary data or analysis For instance if a cross-product regulatory strategy project is underway the Manager might supply the compiled country requirements or recent regulatory changes needed for decision-making They help ensure that agreed intelligence deliverables are executed on time and that any intelligence requests from internal stakeholders are addressed promptly Progress Tracking Improvement Monitor the progress of intelligence-gathering activities against the team s objectives and timelines The Manager tracks their assignments e g monitoring tasks or updates due and regularly reports status to the RI Director If there are delays or obstacles in obtaining information the Manager flags these and helps troubleshoot solutions Additionally the Manager contributes to process improvement discussions - identifying any inefficiencies in how intelligence data is collected or shared and suggesting enhancements They participate in continuous improvement of the function s processes and tools helping to refine workflows for greater efficiency and reliability Knowledge Skills Regulatory Knowledge A solid grounding in regulatory affairs processes and requirements is needed The Manager should understand regulatory submission guidelines and procedures across different regions major markets and smaller markets and have familiarity with how local regulations impact drug development and filings While they may rely on senior staff for deeper analysis the Manager must be able to interpret regulatory documents or health authority guidance and extract key points The ability to handle complex information and distill it into clear summaries is crucial - often the Manager will be the first to review new regulations and must highlight what matters to Amgen s products Attention to Detail and Analytical Skills The role requires strong analytical abilities and attention to detail The Manager will be dealing with regulatory texts tracking changes and inputting data into intelligence systems - so accuracy is paramount They should be skilled at comparing regulatory requirements and spotting differences or trends At the same time they need to maintain a big-picture view to recognize how a particular change might affect Amgen s global filing strategy Being able to propose practical solutions or escalate important findings is part of this analytical skill set Technical and Project Skills Proficiency in using information systems and databases is important as this role often acts as the power user of regulatory intelligence tools Experience with managing or configuring databases spreadsheets or tracking tools will be useful The Manager should also have good project coordination skills - capable of managing their own workstreams meeting deadlines and juggling multiple intelligence requests or projects Strong written and oral communication skills are needed to draft clear reports and to communicate findings to the team or other stakeholders Additionally a willingness to learn and even create new technical solutions e g leveraging an internal SharePoint site or an intelligence software platform is highly valued in this position Qualifications Education Experience It is recommended that candidates have at least a Bachelor s degree in a relevant discipline such as life sciences or regulatory affairs plus relevant experience in regulatory or drug development roles An advanced degree Master s or higher in a related field is a plus While Amgen s internal templates for similar roles have sometimes listed lower educational minima e g associate degree or high school with significant years of experience for a Regulatory Intelligence Manager it is preferable to require a Bachelor s degree as the minimum qualification This ensures the candidate has a sufficient foundation to grasp complex regulatory information In terms of experience a few years of hands-on regulatory affairs or regulatory operations experience for instance 3-5 years with a Bachelor s degree would likely be expected given the need to work independently and with understanding of the regulatory context Preferred Background Relevant industry experience in pharmaceutical biotech regulatory affairs or compliance is strongly preferred Experience specifically with regulatory intelligence or policy tracking - whether in a prior role or via project work - would allow a new hire to hit the ground running Familiarity with regulatory intelligence tools or subscription databases such as Tarius or similar services and experience interacting with global regulatory colleagues would also be advantageous The ideal candidate will be one who not only has the technical skills to manage data and tools but also the curiosity and insight to understand why regulatory changes matter and how to communicate those insights effectively What you can expect of us As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being From our competitive benefits to our collaborative culture we ll support your journey every step of the way In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards Apply now for a career that defies imagination Objects in your future are closer than they appear Join us careers amgen com 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 and live the Amgen values to continue advancing science to serve patients Together we compete in the fight against serious disease Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment Please contact us to request accommodation