*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.