Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.
Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
Independently facilitate project team meetings.
Superior oral and written communication skills.
Ability to work cooperatively with all levels and types of global personnel required.
Experience working with electronic document management systems.
Ability to work independently. Manage multiple projects simultaneously.
Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary.
Requirements:
Minimum of a BA/BS Degree in Chemical, and/or Biological Sciences/relevant discipline.
Required Experience is 4 years pharmaceutical. 1-2 years cross functional project management.
Preferred Experience is 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3).
Regulatory submission documentation creation background.
Detail/accuracy oriented, collaborative and willing to learn.
Familiarity with US and other international regulatory requirements for dossiers.