Senior Regulatory Affairs Manager

Responsibilities

• Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle.
• Ensure strategic alignment with the Clinical Development Plan (CDP) and nonclinical development plan with input from clinical and nonclinical Subject Matter Experts (SMEs), respectively, and regional regulatory leads.
• Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate.
• In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the global nonclinical and clinical development strategy.
• Incorporate RA INTL guidance on development programs (i.e., INTL requirements or policies that may impact clinical development and commercialization).
• Develop global pediatric strategy; collaborate with regional leads on the content for regional pediatric plans (e.g., PIP); ensure global pediatric strategy is reflected in the Global Regulatory Plan; ensure any changes to CDP or Nonclinical development plans are assessed by regional leads for impact to pediatric plan agreements with Health Authorities.
• Lead/support strategy for life-cycle expansion opportunities
• Clinical and Nonclinical Development Plan Advancement
• Act as a key contributor to the Clinical and Nonclinical Development Plans and ensure that they incorporate consideration of current global health authority precedents and regulatory guidance.
• Contribute critically to the scientific interpretation and integration of clinical and nonclinical study results.

Qualifications

• Education: Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelor's acceptable with relevant experience.
• Experience: 6 + years with PhD; 8+ years with Masters or Bachelor's degrees
• Nonclinical / Clinical Regulatory Affairs experience preferred