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 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. #J-18808-Ljbffr