Policy Strategist
2 months ago
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.) In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the global nonclinical and clinical development strategy.
INTL requirements or policies that may impact clinical development and commercialization).collaborate with regional leads on the content for regional pediatric plans (e.g., ensure global pediatric strategy is reflected in the Global Regulatory Plan; 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.
Broadly, ensure that the clinical and nonclinical content is adequately presented in submissions leading to successful clinical trial applications and product approvals.
Lead planning and preparation of core clinical and nonclinical content for global clinical trial applications, collaborating with SMEs and regional regulatory representatives.
Lead the creation of the clinical and nonclinical content of core CTD / global dossier for use in global marketing applications, collaborating with SMEs and regional regulatory representatives.
Directly responsible for nonclinical/clinical aspects of US marketing applications, maintaining US license and ensuring fulfillment of any PMRs/PMCs.Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred; Masters/bachelor's acceptable with relevant experience.
3+ year experience with PhD; 4+ years with master's or bachelor's degrees.
Nonclinical / Clinical Regulatory Affairs experience preferred.
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