Fladger Associates

 


Regulatory Affairs Manager II

Responsibilities:

  • Excellent employment opportunity for a Regulatory Affairs Manager II in the Spring House, PA area.
  • Responsible for routine regulatory support and for providing guidance to support timely filings and maintenance of assigned programs.
  • Develop and communicate regulatory support with the goal of achieving timelines and milestones.
  • Coordinate meetings, solicits agenda topics from team members for regulatory team meetings as well as produces meeting summaries/minutes.
  • Collaborate with pertinent team members to ensure that deliverables are available in a timely manner.
  • Assist in managing time?sensitive submission projects.

Experience:

  • To be considered for this Regulatory Affairs Manager II job opportunity a minimum of a Bachelor's degree is required.
  • Must be knowledgeable of applicable global regulations, guidance documents and regulatory pathways.
  • Experience with regulatory submissions and approval processes is highly preferred.
  • Understanding of IND, NDA, and eCTD dossier component requirements is preferred
  • Knowledge of GCP and GMP, clinical development, and clinical trial processes.

Send Resume To info@fladgerassociates.net  and include Job Title In Subject Line