REGULATORY AFFAIRS & COMPLIANCE OPPORTUNITIES

Always with the patient in mind, we continually strive for recognition as an industry-leading global regulatory affairs organisation that designs and delivers optimised global regulatory strategies, plans and dossiers that align with AbbVie’s overall business strategy.

Chemistry, Manufacturing and Controls (CMC)

CMC regulatory professionals develop and execute CMC regulatory strategies for all AbbVie investigational and marketed products in alignment with the corresponding global regulatory strategy. Areas of expertise include:

• Small Molecules & Biologics
  Develop and execute global CMC regulatory strategies for development compounds from first-in-human studies through marketing applications for marketed products.   
• Devices
  Develop strategies to support new and marketed medical devices (PMAs and 510k applications). 
• Strategic Initiatives
  Support CMC-specific regulatory intelligence and policy issues, develop CMC lifecycle management opportunities and serve as part of a rapid response team for marketed product events.

Global LabelLing, Advertising and Promotion

Our global labelling, advertising and promotion professionals provide expertise in three key areas:

• Global Labelling Strategy
  Oversee strategic input on labeling, develop and maintain company core data sheets (CCDS) ,United States product inserts (USPIs) and summary of product characteristics (SPCs) for all AbbVie pharma products, and manage the National Label Change Request (NLCR) process.
• Advertising & Promotion
  Collaborate with U.S. and international marketing, medical and legal to review all promotional and advertising materials for compliance; identify and develop key pre-clearance strategies with the Office of Prescription Drug Promotion (OPDP) on direct-to-consumer (DTC) campaigns, iPad and iPhone materials, health economics outcome research (HEOR) materials and social media tools; and oversees promotional review process of regulations, new guidance documents and relevant enforcement actions.
• Global Labelling, Compliance & Operations
  Oversee labelling compliance (ensuring filing across all affiliates), Global Labelling System (GLS), maintenance of system and creation of structured product labelling (SPL) and process improvements.

Global Product Strategy

Global product strategy professionals assume responsibility for global regulatory strategies for all products and compounds within Regulatory Affairs. This involves proactively identifying, assessing and mitigating regulatory risks to the portfolio. Global regulatory leads and manages this process by providing a single regulatory voice for each product. 

Regulatory Operations

Regulatory operations professionals oversee the regulatory aspects of in-licensing, acquisition and product divestiture opportunities and lead all regulatory due diligence of business development candidates. Professional services teams create and implement RA quality systems, deliver training services and lead operational standardisation and cost efficiencies while delivering RA production services (publishing, records and registration management) and coordinating RA shared services.

Regulatory Policy & Intelligence

Regulatory policy and intelligence professionals share regulatory knowledge and insight that impact product and policy development on a global level. By interpreting policy and industry trends, advising on agency interactions and sharing regulatory lessons learned, these professionals help users navigate policy issues and minimise regulatory risks. Additionally, they provide critical intelligence that is crucial to AbbVie's success.

EXPERIENCED HIRES »