Director, RA Global Regulatory Strategy

Role Summary

The Director, Regulatory Affairs Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for products in the obesity/metabolic therapeutic area. This role leads the Global Regulatory Product Team (GRPT) and the Labeling Regulatory Strategy Team (LRST), serves as the primary regulatory interface with AST and supporting teams, and ensures strategic messaging and content of global regulatory dossiers. The position proactively mitigates regulatory risks, ensures compliance with global regulatory requirements, and manages compounds through all development phases and lifecycle management, including post-approval.

Responsibilities

• Interfaces with the LRST and AST to lead and support cross-functional company objectives. Leads the GRPT to develop creative global strategies aligned with regulations to achieve business objectives for development and marketed products. When necessary, seeks expert advice and technical support from functional stakeholders, supervisor, and TA Head level personnel.
• Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory agency requests.
• Accountable for ensuring that corporate goals are met. Acts as a key internal leader and driver of regulatory policy and strategy for assigned products.
• Leads preparation of global regulatory product strategies for assigned products. Proactively leads regulatory and cross-functional teams in risk assessment and mitigation strategy development and communicates the plan to relevant stakeholders.
• Acts independently under the direction of a GRS Sr GRL or TA Head. May participate in or lead regulatory and company initiatives. Expands knowledge of TA and provides coaching and mentoring for GRPT members. May have direct reports and contribute to performance management for other RA team members.
• Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization with worldwide accountability for assigned products.
• Follows company policies and procedures for regulatory record keeping and may identify the need to develop and implement policies and procedures within the RA department, ensuring direct reports follow requirements where applicable.
• Ensures alignment of global regulatory strategies with senior management. Under minimal guidance, presents regulatory assessments and recommendations to executive management and informs AST and cross-functional management of issues, labeling outcomes, approvals or risks and mitigations, and impact on global programs. Represents AbbVie's regulatory position in Joint Governance interactions.
• Makes decisions regarding work processes or plans to achieve program objectives established by senior management. Participates in and leads professional associations, industry, and trade groups as appropriate.
• Monitors budget allocations and keeps the supervisor informed on project resourcing. Chairs or sponsors key GRS initiatives and presents outcomes to RA LT.

Qualifications

• Required: 7+ years of regulatory experience; drug development experience in US & C region; proven 5+ years in strategic leadership with strong project management skills; experience in a complex, matrix environment with multiple stakeholders and cross-functional influence; experience interfacing with major government regulatory bodies; strong communication and proactive negotiation skills; experience developing and implementing successful global regulatory strategies.
• Preferred: 10+ years of pharmaceutical regulatory experience, with lead regulatory product strategist experience in two or more major regions in addition to the US (e.g., EU, Japan); strong global development foundation with business acumen; relevant advanced degree preferred; certification a plus.

Education

• 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.

Additional Requirements

• This is a hybrid onsite opportunity. The role has flexibility to be based in AbbVie's Lake County, IL or Florham Park, NJ offices.
• Frequent to continuous computer usage (greater or equal to 50% of the workday) is required.