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 individual leads the Global Regulatory Product Team (GRPT) and 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, and manages compounds in the obesity TA through all phases of development, including post-approval and life cycle management. Develops and implements acceleration strategies and manages projects and necessary documentation of regulatory strategies.

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 achieve business objectives for development and marketed products; seeks expert advice from functional stakeholders and supervisory/TAH-level personnel as needed.
• Leads cross-functional stakeholders to ensure inclusion of strategic messaging in global regulatory dossiers and responses to regulatory agency requests.
• Accountable for ensuring 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; guides risk assessment and mitigation strategy development for assigned products and communicates plans to stakeholders.
• Works independently under supervision; may participate in or lead regulatory initiatives; mentors GRPT members and may have direct reports.
• Influences development of regulations and guidance; analyzes legislation and guidance with worldwide accountability for assigned products.
• Follows policies for regulatory record keeping and may help develop/implement RA 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 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 resources; chairs or sponsors key GRS initiatives and presents outcomes to RA LT.

Qualifications

• 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; drug development experience in US&C region; 5+ years in a strategic leadership role with strong project management skills; experience in a complex matrix environment with multiple stakeholders; experience interfacing with major government regulatory bodies.
• Required Experience cont’d: Strong communication and proactive negotiation skills; experience developing and implementing successful global regulatory strategies.
• Preferred Experience: 10+ years in pharmaceutical regulatory activities, with experience as 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.
• Note: Higher education may compensate for years of experience.

Education

• Bachelor’s degree in life sciences or related field (required).

Additional Requirements

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