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 product(s) in the Oncology therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands therapeutic area knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the 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. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. 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 GRPT to develop creative global strategies aligned with regulations to achieve business objectives for development and marketed products.
• Leads cross-functional stakeholders to ensure clear 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; guides risk assessment and mitigation strategy development for assigned products and communicates plans to stakeholders.
• Works independently under direction of a senior leader; 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; develops and implements procedures within RA as needed; ensures direct reports comply with 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 regulatory position in joint governance interactions.
• Makes decisions on work processes and schedules to meet program objectives; participates in professional associations and industry groups as appropriate.
• Follows budget allocations and communicates resource needs; chairs or sponsors key regulatory initiatives and presents outcomes to RA leadership.

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 in addition to the US (e.g., EU or Japan); strong global drug development foundation with business acumen.
• Note: Higher education may compensate for years of experience.

Education

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject
• Advanced degree preferred; certification a plus