25 ene
Thermo Fisher Scientific
Nuevo Casas Grandes
**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**Office**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 preferred- Experience in Infectious Diseases and/or Biologicals is preferred- Strong knowledge of current US and EU regulations- Strong experience with CTD format and content of regulatory filings- Exceptional 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 EU- Demonstrate 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 documents- Knowledge and understanding of applicable regulations.- Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.