Director, RA Global Regulatory Strategy

Role Summary

The Director, Regulatory Affairs Global Regulatory Strategy develops and implements global strategies to secure and maintain market approval for products in the obesity/metabolic therapeutic area. Leads the Global Regulatory Product Team and interacts with AST and supporting teams to expand subject matter knowledge, ensure strategic messaging in regulatory dossiers, anticipate and mitigate regulatory risks, and manage regulatory strategies through all development stages and life cycle. Hybrid onsite role based in Lake County, IL or Florham Park, NJ.

Responsibilities

• Interface with LRST and AST to lead cross-functional objectives and develop global strategies that align with regulations and business goals for development and marketed products.
• Lead cross-functional stakeholders to ensure clear strategic messaging in regulatory dossiers and responses to regulatory agency requests.
• Accountable for meeting corporate goals and drive regulatory policy and strategy for assigned products.
• Lead preparation of global regulatory product strategies and oversee risk assessment and mitigation planning with the team, and communicate plans to stakeholders.
• Act independently under guidance of senior regulatory leaders, provide coaching and mentoring for GRPT members, and manage direct reports as applicable.
• Influence development of regulations and guidance; analyze legislation and guidance with worldwide accountability for assigned products.
• Ensure compliance with regulatory record-keeping and develop/implement RA policies and procedures as needed.
• Align global regulatory strategies with senior management; present regulatory assessments and recommendations to executive management; inform cross-functional leadership of issues, labeling outcomes, and risk mitigations; represent regulatory positions in Joint Governance.
• Make decisions on work processes and resource plans to achieve program objectives; participate in professional associations and industry groups as appropriate.

Qualifications

• Required Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related field.
• Preferred Education: Advanced degree; professional certification a plus.
• Required Experience: 7+ years regulatory experience, including drug development experience in US & C regions; 5+ years in a strategic leadership role with strong project management skills; experience in a complex matrix environment 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; experience as lead regulatory product strategist in two or more major regions (US plus EU/Japan, etc.); strong global development foundation with business acumen.

Skills

• Global regulatory strategy development
• Cross-functional leadership and matrix collaboration
• Regulatory affairs documentation and risk management
• Regulatory policy and guidance analysis
• Strategic communication and negotiation

Education

• Bachelor’s degree in life sciences or related field; advanced degree preferred

Additional Requirements

• Hybrid onsite role with possible base locations in Lake County, IL or Florham Park, NJ; frequent computer usage (≥50% of workday) required.