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Manager/Senior Manager Regulatory Affairs
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Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
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Nos aseguraremos de que las personas con discapacidades reciban adaptaciones razonables para participar en el proceso de solicitud de empleo o entrevista de trabajo, para que puedan ejercer las funciones de trabajo esenciales y recibir otros beneficios y privilegios del empleo. Comuníquese con nosotros para solicitar una adaptación.