Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Here’s What You’ll Do:

Works with global regulatory lead(s), regulatory strategists, Global Regulatory Sub-Teams and project teams regarding the development and execution of regulatory strategy through the product development lifecycle.Coordinate, develop and contribute to content and format of regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, pediatric plans, DSURs, MAA/BLA/NDA, etc.Identify and assess regulatory risks for assigned projects or programs.Senior Manager may serve as point of contact with regulatory agencies relevant to assigned projects or programs, as appropriate.Ability to work both independently and within project teams, committees, etc. to achieve group goals.Accountable for tracking, following up and archiving correspondence, regulatory commitments, and queries from Health Agencies

Here’s What You’ll Bring to the Table:

BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.5+ years of experience in the Pharmaceutical industry preferred in LATAM Countries.3+ years of experience in Regulatory strategy or relevant training/experience preferredExperience in Infectious Diseases and/or Biologicals is preferredStrong knowledge of current US and EU regulationsStrong experience with CTD format and content of regulatory filingsExceptional written and oral communication in English and Spanish.Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance--preferably from at least both US and EUDemonstrate strong organizational skills, including the ability to prioritize workload.Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.Experience in authoring regulatory documentsKnowledge and understanding of applicable regulations.Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.