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Regulatory Affairs Senior Associate
ConfidentialHyderabad / Secunderabad, Telangana30+ days ago
Job descriptionExhibits 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 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 Bachelor s degree and 6 years of related experience Experience working in a Global Regulatory Affairs organization
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 :
Preferred Knowledge and Skills :
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 :
Skills Required
Regulatory Submissions, Risk Assessment, Clinical Trials, Quality Assurance
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Associate Regulatory • Hyderabad / Secunderabad, Telangana