Associate Director, Regulatory Affairs Lifecycle Management
The Associate Director, Regulatory Affairs Lifecycle Management serves as the subject matter authority relating to dossier management, regulatory records and archiving strategies and practices. This role serves as a liaison to partners outside of Regulatory Affairs (RA) providing accurate and timely information regarding our global asset portfolio both past and present. This leadership position reports to the Director, and is accountable to optimize business processes and requirements to enable reading of regulatory communications globally!
- Balances ambiguity in complex situations with an eye toward process improvement.
- Operates to seek business problems quickly without impacting portfolio achievements and objectives.
- Establishes ownership and authoritative sources of requested information.
- Identifies regulatory affairs roles and quality assurance roles within Abbvie and uses them appropriately to deliver work products.
- May serve as ambassador to the function and deliver educational updates and awareness to support improved regulatory affairs practices. Works as regulatory SME to project teams within the organization.
- Serves as primary liaison to legal affairs and corporate counsel regarding Abbvie portfolio projects and marketed assets globally.
- Supports business process owner in defining and documenting standard methodologies and delivering transparency throughout regulatory affairs.
- Required Education: Bachelor's degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology), math, engineering, business management, or medical field
- Required Experience: - 9 years' related experience - Shown leadership skills and presence - Experience working in a complex and matrix environment - Strong verbal and written communication skills
- Ability to get along with senior management and executives - Ability to work with cross-functional teams - Ability to balance budget and timelines of projects and resources within a program or project - Strong attention to detail and problem solving skills
- Effective use of negotiation skills to problem solve in cross-functional teams to ensure completion of assigned tasks - Keen awareness to cultural nuances; shown experience in a global environment - Proven ability to successfully collaborate with and influence multi-divisional and multi-functional teams from across the globe
- 5-7 years in pharmaceutical, healthcare or regulated industry - Proficient in project planning and management including successful implementation of complex business process initiatives - Experience facilitating process modeling and redesign initiatives - Training and/or experience with process modeling tools - Knowledge of Continuous Improvement/Lean Six Sigma concepts
- Advanced degree in science, math, business management, or engineering is preferred - Certifications such as RAC from the Regulatory Affairs Professionals Society, and/or Project Management Institute (PMI) Project Management Professional (PMP) are preferred
- Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.