HYBRID OUT OF NORTH CHICAGO IL

PAY: $33hr - $35/hr

REQUIRED:

• MS in Reg Affairs with Strong Internship/Co-op exp or Bachelors Degree: Chemistry/ Biology/ Pharmacy/ Other Related Science Degree
• Strong knowledge of eCDT (Module 3) - doc management specialist focusing on CMC documentation
• Must have EDMS (theirs is Decara but any will do), ability to work cross functionally, CMC, eCTD (Module 3), special documents (supporting elements of the dossier)
• Highly prefer project management (demonstrated experience working cross functionally on multiple deliverables) - document management background
• Regulatory submission documentation creation background

Job Description:

• Individual is responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will coordinate activities with all functional departments in support of regulatory filings.
• 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.
• Detail/accuracy oriented, collaborative and willing to learn.
• Familiarity with US and other international regulatory requirements for dossiers.