Regulatory Affairs Senior Associate

ABOUT THE ROLE

The Regulatory Affairs Senior Associate role assists US Promotion Regulatory representatives and other cross-functional roles in the administration of regulatory strategies for department initiatives across all product brands. This role assists with preparing, tracking, reporting, and archiving US regulatory documentation, including preclearance and advisory comment promotional materials, and is responsible for all Ad/Promo regulated data management. This role performs the planning and tracking of all US promotional label changes and manages the system update of promotional labeling and Important Safety Information (ISI). This role is responsible for US digital labeling and tracks team performance and savings for label change implementation.

Roles & Responsibilities:

• Label change updates and implementation process
• Logo & Package Component Labeling (PCL) changes
• Important Safety Information (ISI) updates
• Product shot index management of drug product imagery
• Label change content assessment binders
• System workflow assessments of label impacted promotional material
• Regulatory Information Management (RIM) archiving
• Preclearance & Request for Advisory Comments (RFAC) submissions
• Reporting/Archiving of Ad/ Promo FDA Communications (i.e. Intent to Comply, Record of Contact -ROC, Prescription Drug Marketing Act -PDMA, Dear Healthcare Provider -DHCP letters, etc.)
• Veeva data entry/retrieval and collection of information
• Process documentation authoring support

Required Knowledge and Skills:

• Exhibits a professional manner in dealing with others and maintains constructive working relationships
• Communicates effectively both verbally and in writing with superiors, colleagues, and individuals inside and outside the Company
• Can be depended on to complete work in a timely, accurate, and thorough manner and is conscientious about assignments
• Ability to read and understand written instructions and follow documented process
• Ability to lead and manage video conference meetings (i.e. MS Teams) and provide meeting minutes
• Proficient in MS Word, Excel, PowerPoint, Visio, and to manipulate data using formulas in Excel spreadsheets (including pivot tables)
• Technical editing of process documents and proofreading, with the ability to create Infographics & slides
• Experience in Veeva PromoMats to create Electronic Common Technical Documents (eCTD) compliance packages for US FDA submissions with a strong knowledge of FDA eCTD publishing tools
• Knowledge and experience in the US Medical, Legal, and Regulatory (MLR) review process within Veeva PromoMats to complete Abbreviated Reviews

• Veeva system expertise in the Records Information Management (RIM) Vault to archive & maintain complaint US Health Authority records

• MS SharePoint/Teams expertise to collaborate and help manage department records/process documentation

• MS Outlook inbox management, including organizational skills, creating email rules, and standard email templates

Preferred Knowledge and Skills:

• Previous Amgen (or other biopharmaceutical companies) experience with US Regulatory Advertisement/Promotional (Ad/Promo) expertise
• Previous SharePoint experience navigating and maintaining document records
• Veeva Business Admin certified (PromoMats & RIM)
• US Regulatory Ad/Promo Project Management and knowledge of FDA promotional regulations
• Experience in US labeling and Regulatory document management & promotional review and approval processes

Basic Education and Experience:

Masters degree and 4 years of related experience

OR

Bachelors degree and 6 years of related experience

Preferred Education and Experience:

• Bachelors degree and 6 years of related experience
• Experience working in a Global Regulatory Affairs organization

AIN working hours for this position:

This position supports the Regulatory Promotion and Material Compliance activities serving Amgens US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications.