Regulatory Affairs Sr Mgr (Global Labeling)

The purpose of this group is to facilitate the development & maintenance of drug product core labeling documents that are consistent with regulatory requirements, corporate strategy & Amgen values. Provides quality labeling documents for health authority submissions that reflect regulatory st&ards & key stakeholder contributions & permit the best possible patient & company outcomes. Facilitates & records/tracks labeling reviews & issue resolution. Ensures that labeling documents are accurate, current, consistent, comprehensive, & competitive with other agents in the class. Job Summary:- For development products: Provides strategic & tactical guidance to product strategy teams following the concept of -??Label drives development-? & builds the evidence based development Core Data Sheet (dCDS). - For marketed products: Leads product-specific global labeling development & maintenance activities throughout a product's life cycle. Key Activities:- Evaluates development strategy impact on target product labeling - Identifies & analyzes regulatory requirements & competitive labeling- In collaboration with the product strategy team, builds the evidence-based label & labeling strategies for the product(s)- Leads cross-functional teams in the development & maintenance of TPLs, dCDSs, CDSs, USPIs/PPIs/MGs/DHCP letters & Global Negotiation Documents (GNDs)- Facilitates the corporate review & approval activities for CDS & regional labeling, including regional deviations from the CDS- Ensures alignment of labeling strategy across products- Collaborates with other Product Leads & functional area representatives to ensure adherence to established Amgen processes & corporate st&ards- Coordinates corporate review & approval of cross-product issues within the scope of assigned products/franchises at the discretion of Director- Facilitates implementation discussion of FDA approved product labeling- Creates & maintains cumulative annotated labeling history documents for assigned products/regions- Collaborates with regional affiliates & Business Partner representatives in the development & maintenance of regional drug product labeling- Manages labeling commitments for Business Partners as delineated in partnership/service agreements- Maintains awareness of regulatory legislation pertaining to labeling & assesses & communicates its impact on the business & products of the company- Reviews & assesses impact of draft legislation; provides input on Amgen/industry comments- May be responsible for mentoring & developing direct reports