Address
Form of work Responsibilities:
- 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 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.
Requirements:
- Lead clinical and nonclinical FDA interactions in alignment with corporate and/or program goals.
- Serve as the point of contact for FDA regarding nonclinical/clinical communications.
- Ensure that global HA feedback is incorporated into the clinical and nonclinical aspects of the development programs.
- Broadly, ensure that the clinical and nonclinical content is adequately presented in submissions leading to successful clinical trial applications and product approvals.
- Oversee any CRO/vendors that are contracted to perform any of the regulatory activities related regulatory submissions and HA interactions
- Lead planning and preparation of core clinical and nonclinical content for global clinical trial applications, collaborating with SMEs and regional regulatory representatives.
- Lead collaboration with CROs to support global clinical trials in line with corporate goals.
- Maintain IND/CTAs through end of clinical studies.
- Facilitate US clinical trial results postings on CT.gov.
- 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. Serve as RNC lead on MA Filing Team to support global MA preparation, submission, review through approvals.
- 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.
