Associate Director, Regulatory Strategic Planning
AbbVie
1 month ago
Remote friendly (Irvine, CA)
United States
Corporate Functions
The Associate Director, Regulatory Strategic Planning, is responsible for delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization, combining scientific, regulatory, and business process knowledge to drive execution of regulatory strategies. Develop and manage schedules, activities, and deliverables for Global Regulatory Product Teams (GRPTs), interact with key stakeholders, and lead cross-functional process improvement efforts to achieve regulatory compliance and productivity business goals.
Responsibilities:
- Provide project management leadership for GRPTs; develop schedules and wave plans to plan and track regulatory milestones and drive GRPT activities/deliverables.
- Plan and facilitate GRPT and related meetings; ensure action items are assigned and completed; periodically summarize and share team highlights.
- Interact with ADTs and enterprise stakeholders to ensure regulatory milestones are communicated; provide timely updates to Regulatory management on progress/issues.
- Drive GRPT operations in support of the Global Regulatory Lead (GRL); keep GRPT tools/info (team sites, rosters, charters, schedules) up to date.
- Identify, plan, and execute high-complexity, cross-functional process improvement initiatives; lead change and move ideas from concept to implementation.
- Apply knowledge of regulatory product lifecycle, business processes, and regulations to provide subject matter input and make decisions using prior results/experience.
- Lead team meetings; use project governance to escalate and resolve issues; facilitate consensus on process changes.
- Develop working relationships; prepare and deliver clear written reports and presentations for various audiences.
- Coordinate deliverable preparation; develop/maintain process models; manage and track budgets, contracts, communications, metrics, and reporting processes.
- Identify, capture, and report business performance metrics; analyze with SMEs to improve compliance, quality, and productivity.
Qualifications:
- Bachelor’s degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology), math, engineering, business management, or medical field.
- Advanced degree preferred (science, math, business management, engineering). RAC (RAPS) and/or PMP (PMI) preferred.
- 9 years’ related experience.
- Proven leadership; experience in complex/matrix environments.
- Strong verbal and written communication; ability to interact with senior management/executives.
- Ability to work with cross-functional teams.
- Ability to manage budgets and project/program timelines; strong attention to detail and problem solving.
- Strong negotiation skills; cultural awareness; proven global experience influencing multi-divisional, multi-functional teams.
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) (eligible employees).
- Eligible for long-term incentive programs.
Responsibilities:
- Provide project management leadership for GRPTs; develop schedules and wave plans to plan and track regulatory milestones and drive GRPT activities/deliverables.
- Plan and facilitate GRPT and related meetings; ensure action items are assigned and completed; periodically summarize and share team highlights.
- Interact with ADTs and enterprise stakeholders to ensure regulatory milestones are communicated; provide timely updates to Regulatory management on progress/issues.
- Drive GRPT operations in support of the Global Regulatory Lead (GRL); keep GRPT tools/info (team sites, rosters, charters, schedules) up to date.
- Identify, plan, and execute high-complexity, cross-functional process improvement initiatives; lead change and move ideas from concept to implementation.
- Apply knowledge of regulatory product lifecycle, business processes, and regulations to provide subject matter input and make decisions using prior results/experience.
- Lead team meetings; use project governance to escalate and resolve issues; facilitate consensus on process changes.
- Develop working relationships; prepare and deliver clear written reports and presentations for various audiences.
- Coordinate deliverable preparation; develop/maintain process models; manage and track budgets, contracts, communications, metrics, and reporting processes.
- Identify, capture, and report business performance metrics; analyze with SMEs to improve compliance, quality, and productivity.
Qualifications:
- Bachelor’s degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology), math, engineering, business management, or medical field.
- Advanced degree preferred (science, math, business management, engineering). RAC (RAPS) and/or PMP (PMI) preferred.
- 9 years’ related experience.
- Proven leadership; experience in complex/matrix environments.
- Strong verbal and written communication; ability to interact with senior management/executives.
- Ability to work with cross-functional teams.
- Ability to manage budgets and project/program timelines; strong attention to detail and problem solving.
- Strong negotiation skills; cultural awareness; proven global experience influencing multi-divisional, multi-functional teams.
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) (eligible employees).
- Eligible for long-term incentive programs.