Director, RA Global Regulatory Strategy

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.

Role Overview

The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. Develops and implements acceleration strategies. Manages projects and necessary documentation of reg strategies.

Responsibilities

• Interfaces with the LRST and AST to lead and support cross-functional company objectives. Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products.
• Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in global regulatory dossiers and responses to regulatory Agency requests.
• Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.
• Leads preparation of global regulatory product strategies; leads risk assessment and mitigation strategy development and communicates plans to stakeholders.
• Acts independently under the direction of a GRS Sr GRL or TA Head. Provides coaching and mentoring for GRPT members. May have direct report(s).
• Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance with worldwide accountability for assigned products.
• Follows company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department.
• Ensures alignment of global regulatory strategies with Sr. Management; presents regulatory assessments and recommendations to executive management. Represents ABBV Regulatory position at Joint Governance.
• Makes decisions regarding work processes, operational plans and schedules; takes leadership roles in professional associations, industry, and trade groups.
• Follows budget allocations and keeps supervisor informed on project resourcing. Chairs or sponsors key GRS initiatives and presents outcomes to RA LT.

Required Education

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject

Preferred Education

• Relevant advanced degree is preferred. Certification a plus.

Required Experience

• 7+ years regulatory experience; requires drug development experience in US&C region.
• Proven 5+ years in a strategic leadership role with strong project management skills.
• Experience working in a complex matrix environment, influencing cross-functional teams, and interfacing with major government regulatory agencies.
• Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies.

Preferred Experience

• 10+ years' experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan.
• Strong global drug development foundation with business acumen.
• Note: Higher education may compensate for years of experience.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Eligible for long-term incentive programs

AbbVie is an equal opportunity employer. Equal Opportunity Employer/Veterans/Disabled.