Job Description
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 AbbVie and with Health Authorities. Provides strategic design, implementation, and ongoing improvements of regulatory business capabilities. The individual is generally considered a key opinion leader and an expert resource both within AbbVie and externally, influencing changing regulations and guidance, interfacing with outside regulatory agencies, and providing executive management with RIM metrics and reports.
- Proposes and executes enhancement within the Regulatory Information Management vision, providing strategic design, development, and implementation plans for the RIM Solution (Cosmos) and working 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, working 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, forging agreements among sponsors to drive enterprise benefit.
- Oversees the implementation and maintenance of robust data to ensure accuracy, consistency, and integrity of regulatory information, leading ongoing data review and improvement initiatives and collaborating with cross‑functional teams to resolve discrepancies and ensure compliance with regulatory requirements.
- Drives continuous improvement of the RIM system by maintaining deep expertise in its functionality and user needs, optimizing supporting materials—including training programs and job aids—and providing effective training to staff. Represents RIM in internal and external forums, including staff meetings, regional meetings, and conferences.
- Defines key performance indicators (KPIs) and metrics to measure success and impact of ongoing activities and innovation efforts, reporting progress to leadership.
- Leverages expertise and ownership of regulatory information to support inspections.
- Frames complex issues for decision makers, preparing and delivering effective presentations that lead to actionable results, drawing upon personal knowledge of RA business processes, global regulations, and process improvement methods to propose and design innovative business process improvements.
- Works independently, demonstrating organizational influence within or across regulatory and partner functions.
- Identifies and leads project team members effectively without direct authority, motivating performance, resolving conflicts, and mitigating risks.
Qualifications
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’ experience in pharmaceutical, device, or related industry.
- 5 years of experience leading a team.
- Previous Life Science leadership role with strong management skills.
- Strong communication skills, both oral and written.
- Strong business acumen and negotiating skills.
- Experience working in a complex and matrix environment.
- Ability to craft compelling business cases and sell new ideas.
- Proficiency in project planning and management, including successful implementation of complex initiatives.
Additional Information
- Compensation: The range described below is the potential base pay compensation for this role. Actual compensation within this range depends on factors such as geographic location and individual performance. This range may be modified in the future.
- Benefits: A comprehensive package of benefits, including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) plan for eligible employees.
- Long‑term incentive programs: This job is eligible to participate in AbbVie’s long‑term incentive programs.
AbbVie 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.
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