Regulatory Affairs Senior Associate

Location: Prakāshamnagar

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 Promo Mats 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 Promo Mats 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 (Promo Mats & 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:

Master s degree and 4 years of related experience
OR
Bachelor s degree and 6 years of related experience
Preferred

Education and Experience:

Bachelor s degree and 6 years of related experience
Experience working in a Global Regulatory Affairs organization