Regulatory Consultant Cmc - Small Molecule (Bogotá)

Qualifications

• Previous CMC with Biologics is required
• Veeva Vault RIM experience is required
• Open to NA and LATAM - must work EST hours.

Responsibilities

• Conduct research of existing product data relative to general or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
• Manage and/or operationalize the delivery of day‑to‑day regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
• Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
• Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
• Support meetings with clients to discuss proposals, the status of ongoing projects, and as part ...