Director, RA Global Regulatory Strategy

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$/yr - $/yr

Company Description
Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

Job Description
The Director, Regulatory Affairs Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for products in the obesity/metabolic therapeutic area. This individual leads the Global Regulatory Product Team and Labeling Regulatory Strategy Team. Serves as the primary regulatory interface with AST and supporting teams.

Responsibilities:

• Interfaces with the LRST and AST to lead and support cross-functional company objectives.
• Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests.
• Accountable for ensuring that corporate goals are met.
• Leads preparation of global regulatory product strategies for assigned products.
• Acts independently under the direction of a GRS Sr GRL or TA Head.
• Influences the development of regulations and guidance.
• Follows company policies and procedures for regulatory record keeping.
• Ensures alignment of global regulatory strategies with Sr. Management.
• Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management.

Qualifications:

• Required
  
  Education:
  
  Bachelor’s degree in life sciences or related subject.
• Preferred Education:
  
  Relevant advance degree is preferred.
• Required Experience:
  
  7+ years regulatory experience.
• Require experience cont’d:
  Strong communication and proactive negotiation skills.
• Preferred Experience:
  
  10+ years experience in pharmaceutical regulatory activities.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.