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 and the Labeling Regulatory Strategy Team, interfaces with regulatory authorities and cross-functional teams, and manages regulatory strategy across all development stages and product life cycles.

Responsibilities

• Interfaces with the LRST and AST to lead and support cross-functional objectives; leads the GRPT to develop global strategies aligned with regulations to meet business objectives for development and marketed products.
• Leads cross-functional teams to ensure inclusion of strategic messaging in global regulatory dossiers and responses to regulatory agency requests.
• Accountable for ensuring corporate goals are met; drives regulatory policy and strategy for assigned products.
• Leads preparation of global regulatory product strategies; leads risk assessment and mitigation planning and communicates plans to stakeholders.
• Acts independently under senior guidance; may participate in or lead initiatives; provides coaching and mentoring for GRPT members; may have direct reports.
• Influences regulation and guidance; analyzes legislation and guidance with worldwide accountability for assigned products.
• Follows policies for regulatory record keeping and may develop department policies; ensures direct reports follow requirements.
• Ensures alignment of global regulatory strategies with senior management; presents regulatory assessments and recommendations to executive management; informs stakeholders of issues and mitigations; represents AbbVie regulatory position in governance discussions.
• Makes decisions on work processes and schedules to achieve program objectives; participates in professional associations and industry groups as appropriate.
• Manages budget and resource planning; chairs or sponsors key GRS initiatives and reports outcomes to RA LT.

Qualifications

• Required Education: Bachelor‚Äôs degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• Preferred Education: Relevant advanced degree; certification a plus.
• Required Experience: 7+ years regulatory experience with drug development experience in US & C region; 5+ years in strategic leadership with strong project management; experience in complex matrix environments and interfacing with major regulatory bodies; strong communication and negotiation skills; experience developing and implementing global regulatory strategies.
• Preferred Experience: 10+ years in pharmaceutical regulatory activities, lead regulatory product strategist in two or more major regions in addition to the US (e.g., EU, Japan); strong global development foundation with business acumen.

Skills

• Strategic regulatory planning
• Cross-functional leadership
• Regulatory dossier preparation and responses
• Risk assessment and mitigation
• Stakeholder management and communication
• Policy development and governance
• Budgeting and resource management

Education

• Bachelor‚Äôs degree in life sciences or related field; advanced degree preferred.

Additional Requirements

• This is a hybrid onsite opportunity based in Lake County, IL or Florham Park, NJ.
• Frequent to continuous computer usage (‚â•50% of the workday).