Associate Director, Regulatory Strategic Planning

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, driving execution of regulatory strategies. Responsibilities include developing and managing schedules, activities, and deliverables for Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and leading cross-functional process improvement efforts to achieve regulatory compliance and productivity goals.

Responsibilities:
- Provide project management leadership for GRPTs; develop schedules and wave plans to plan and track regulatory milestones; work with Regulatory staff globally to execute GRPT activities and deliverables.
- Plan and facilitate GRPT meetings (e.g., Dossier Kick-off Meetings, Regulatory Strategic Reviews, Rapid Response Teams, Regulatory Advisory Panels); ensure action items are assigned and completed; share team highlights with stakeholders.
- Interact with ADTs and enterprise stakeholders to ensure regulatory milestones are communicated; provide timely updates to Regulatory management on progress and issues impacting global programs.
- Drive GRPT operations in support of the Global Regulatory Lead (GRL); keep GRPT information/tools up to date (team sites, rosters, charters, schedules).
- Identify, plan, and execute high-complexity, cross-functional process improvement initiatives; demonstrate change leadership from concept to implementation.
- Apply extensive knowledge of regulatory product lifecycle, business processes, and regulations; provide business subject matter knowledge; use problem solving/decision making and continuous learning.
- Lead team meetings; use project governance to escalate and resolve issues; facilitate groups and drive consensus on process changes.
- Build working relationships; prepare and deliver clear written reports and presentations for varied 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 (Regulatory Affairs Professionals Society) and/or PMP (PMI) preferred.
- 9 years’ related experience.
- Proven leadership skills and presence.
- Experience in complex matrix environments.
- Strong verbal and written communication skills.
- Ability to interact with senior management/executives and work with cross-functional teams.
- Ability to manage project/program budgets and timelines; strong attention to detail and problem solving.
- Strong negotiation skills in cross-functional teams; cultural nuance awareness; proven global experience influencing multi-divisional, multi-functional teams.

Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) (eligible employees).
- Eligible for long-term incentive programs.