Regulatory Affairs AssociateII; CMC

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.

• Responsible for managing and compiling CMC sections of marketed product variations.
• Partner with RA CMC Project Leads and develop module 3 content and project timelines.
• Collaborate with diverse functional groups to ensure file‑ability and acceptance of CMC sections.
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
• Run review meetings for submission documents.
• Understand CMC expectations including CTD content, structural and formatting requirements.
• Maintain awareness of and utilize current best practices for use of regulatory business systems within the group.

• Bachelor's degree in science, 4 years pharmaceutical; 1-2 years cross‑functional project management.
• Minimum of a BA/BS Degree in Chemical, and/or Biological Sciences/relevant discipline with 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module
  3).
• Regulatory submission documentation creation background.
• 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.