Associate Director, Regulatory Strategic Planning
AbbVie
1 month ago
Remote friendly (North Chicago, IL)
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 track regulatory milestones; work with Regulatory staff globally to execute GRPT activities and deliverables.
- Independently 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 supporting 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 from concept to implementation.
- Apply extensive knowledge of the regulatory product lifecycle, business processes, and regulations; provide business subject matter knowledge; solve problems and make decisions; learn and adjust based on prior results/experience.
- Lead team meetings using project governance; escalate and drive resolution of issues; facilitate groups and build consensus on process changes.
- Develop working relationships; prepare and deliver clear, relevant written reports and presentations for varied audiences.
- Coordinate and drive deliverable preparation; develop and 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.
Qualifications:
- Bachelor’s degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology), math, engineering, business management, or a medical field.
- Advanced degree in a relevant field preferred.
- Certifications such as RAC (RAPS) and/or PMI PMP preferred.
- 9 years’ related experience.
- Proven leadership; ability to work 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 timelines/resources; strong attention to detail and problem-solving.
- Strong negotiation skills; cultural awareness; proven global collaboration and influence across multi-divisional, multi-functional teams.
Responsibilities:
- Provide project management leadership in support of Global Regulatory Product Teams (GRPTs); develop schedules and wave plans to track regulatory milestones; work with Regulatory staff globally to execute GRPT activities and deliverables.
- Independently 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 supporting 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 from concept to implementation.
- Apply extensive knowledge of the regulatory product lifecycle, business processes, and regulations; provide business subject matter knowledge; solve problems and make decisions; learn and adjust based on prior results/experience.
- Lead team meetings using project governance; escalate and drive resolution of issues; facilitate groups and build consensus on process changes.
- Develop working relationships; prepare and deliver clear, relevant written reports and presentations for varied audiences.
- Coordinate and drive deliverable preparation; develop and 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.
Qualifications:
- Bachelor’s degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology), math, engineering, business management, or a medical field.
- Advanced degree in a relevant field preferred.
- Certifications such as RAC (RAPS) and/or PMI PMP preferred.
- 9 years’ related experience.
- Proven leadership; ability to work 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 timelines/resources; strong attention to detail and problem-solving.
- Strong negotiation skills; cultural awareness; proven global collaboration and influence across multi-divisional, multi-functional teams.