Associate Director, Regulatory Strategic Planning
AbbVie
1 month ago
Remote friendly (South San Francisco, CA)
United States
Corporate Functions
Associate Director, Regulatory Strategic Planning
Responsibilities:
- Provide project management leadership in support of Global Regulatory Product Teams (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 and related 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/or issues impacting global programs.
- Drive GRPT operations in support of the Global Regulatory Lead (GRL); keep GRPT information and tools (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 deep knowledge of regulatory product lifecycle, business processes, and regulations across Regulatory sub-functions; solve problems and make decisions; learn and adjust based on prior results.
- Lead team meetings; use project governance to escalate and resolve issues; facilitate groups and drive consensus on process changes.
- Develop 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-related processes.
- Identify, capture, and report business performance metrics; analyze with SMEs to improve compliance, quality, and productivity; incorporate global perspectives to improve Regulatory Affairs outcomes.
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, or engineering). Preferred certifications: RAC (Regulatory Affairs Professionals Society) and/or PMP (PMI).
- 9 years’ related experience.
- Proven leadership; experience in a complex, matrix environment.
- Strong verbal and written communication skills.
- Ability to interact with senior management/executives and work with cross-functional teams.
- Ability to manage budgets and project timelines/resources; strong attention to detail and problem solving.
- Effective negotiation skills to resolve cross-functional issues; awareness of cultural nuances; proven ability to work globally and influence multi-divisional, multi-functional teams.
Benefits (explicitly stated):
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k) to eligible employees
- Eligibility to participate in long-term incentive programs
Responsibilities:
- Provide project management leadership in support of Global Regulatory Product Teams (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 and related 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/or issues impacting global programs.
- Drive GRPT operations in support of the Global Regulatory Lead (GRL); keep GRPT information and tools (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 deep knowledge of regulatory product lifecycle, business processes, and regulations across Regulatory sub-functions; solve problems and make decisions; learn and adjust based on prior results.
- Lead team meetings; use project governance to escalate and resolve issues; facilitate groups and drive consensus on process changes.
- Develop 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-related processes.
- Identify, capture, and report business performance metrics; analyze with SMEs to improve compliance, quality, and productivity; incorporate global perspectives to improve Regulatory Affairs outcomes.
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, or engineering). Preferred certifications: RAC (Regulatory Affairs Professionals Society) and/or PMP (PMI).
- 9 years’ related experience.
- Proven leadership; experience in a complex, matrix environment.
- Strong verbal and written communication skills.
- Ability to interact with senior management/executives and work with cross-functional teams.
- Ability to manage budgets and project timelines/resources; strong attention to detail and problem solving.
- Effective negotiation skills to resolve cross-functional issues; awareness of cultural nuances; proven ability to work globally and influence multi-divisional, multi-functional teams.
Benefits (explicitly stated):
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k) to eligible employees
- Eligibility to participate in long-term incentive programs