Director, Regulatory Affairs Information Management

Director of Regulatory Information Management

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.

The Director of Regulatory Information Management (RIM) leads the advancement of business capabilities to enable efficient, consistent, and compliant use, and management, of Regulatory information across Abb Vie and with Health Authorities. Provides strategic design, implementation, and ongoing improvements of Regulatory business capabilities. In addition, the individual is generally considered a key opinion leader and an expert resource both within Abb Vie and externally.

The individual may influence changing regulations and guidance, interface with outside regulatory agencies and provide executive management with RIM metrics and reports.

• Proposes and executes enhancement within the Regulatory Information Management vision. Provides strategic design, development, and implementation plans for the RIM Solution (Cosmos), and works alongside BTS, Business SMEs, and stakeholders to propose and lead the execution of these plans.
• Provides strategic design, implementation, and ongoing improvements of Regulatory business capabilities, and works closely with Regulatory Business Process Owners and other internal partners to identify, prioritize, and deliver sound RIM processes and supporting technologies in support of Regulatory strategies.
• Leverages a working knowledge of Regulatory business processes across the complete drug product lifecycle including A&A, Safety, Clinical, Development, PDS&T, Quality, and Operations to transform improvement concepts into executable initiatives. Seeks input from and forges agreements among sponsors regarding initiative goals and objectives across multiple domains to drive benefit across the enterprise.
• Oversee the implementation and maintenance of robust data to ensure the accuracy, consistency and integrity of regulatory information. Lead ongoing data review and improvement initiatives and collaborate with cross-functional teams to resolve discrepancies and ensure compliance with regulatory requirements.
• Drive continuous improvement of the Regulatory Information Management (RIM) system by maintaining deep expertise in its functionality and user needs. Advance RIM solutions, optimize supporting materials—including training programs and job aids—and provide effective training to staff. Represent RIM in internal and external forums, including staff meetings, regional meetings, and conferences.
• Define key performance indicators (KPIs) and metrics to measure the success and impact of ongoing activities and innovation efforts, regularly reporting progress to leadership.
• Leverage expertise and ownership of Regulatory Information to support inspections.
• Effectively frames complex issues for decision-makers. Prepares and delivers effective presentations that lead to actionable results. Draws upon personal knowledge of RA business processes, global regulations, and process improvement methods to propose and design innovative business process improvements.
• Works independently in a role that demonstrates organizational influence within or across Regulatory and partner functions.
• As applicable, identifies and leads project team members effectively without direct authority; motivates to drive performance, resolve conflicts and mitigate risks.

Required

Education:

• Bachelor's degree in business management, information systems, engineering, math, science (e.g., biology, chemistry, pharmacy, medical), or related field

Required Experience:

• 12+ years' pharmaceutical, device, or industry related experience
• 5 years of experience leading a team
• Previous Life Science leadership role with strong management skills
• Strong communication skills, both orally and written
• Strong business acumen and negotiating skills
• Experience working in a complex and matrix environment
• Ability to craft compelling…