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 TA. This role leads the Global Regulatory Product Team and Labeling Regulatory Strategy Team, serves as the primary regulatory interface with AST and supporting teams, and ensures strategic messaging and content of global regulatory dossiers. It also involves managing compounds through all development phases, including post-approval, and driving acceleration strategies.

Responsibilities

• Interfaces with the LRST and AST to lead and support cross-functional objectives; leads the GRPT to develop global strategies in line with regulations to achieve business objectives for development and marketed products.
• Leads cross-functional stakeholders to ensure inclusion of strategic messaging in global regulatory dossiers and responses to regulatory Agency requests.
• Accountable for meeting corporate goals; acts as a 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.
• Operates independently under senior guidance; may participate in or lead regulatory initiatives; provides coaching and mentoring for GRPT members; may have direct reports.
• Influences the development of regulations and guidance; analyzes legislation and guidance with worldwide accountability for assigned products.
• Follows policies for regulatory record keeping; may develop new policies and ensure compliance within the RA department.
• Ensures alignment of global regulatory strategies with senior management; presents regulatory assessments and recommendations to executive management; informs cross-functional management of issues and mitigations; represents ABBV regulatory position in Joint Governance.
• Makes decisions on work processes and schedules to achieve program objectives; participates in professional associations and industry groups as appropriate; manages budget and resourcing; chairs or sponsors key GRS initiatives.

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; drug development experience in US & C region; 5+ years in a strategic leadership role with strong project management; experience in a complex matrix environment; experience interfacing with major regulatory bodies.
• Required Experience Cont‚Äôd: Strong communication and proactive 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 besides the US (e.g., EU or Japan); strong global development foundation with business acumen.

Skills

• Strategic regulatory planning
• Cross-functional leadership
• Regulatory risk assessment and mitigation
• Global regulatory strategy development
• Stakeholder management and influence
• Communication and negotiation
• Regulatory policy and guidance analysis

Education

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

Additional Requirements

• Hybrid onsite role based in Lake County, IL or Florham Park, NJ; frequent to continuous computer usage (‚â•50% of workday).