RA CMC Associate / Post-Approval Dossier Manager

Posted 29 March 2023
Salary US$35 - US$38 per hour
Job type Contract
DisciplineLife Science Recruitment
Contact NameColin Murray-Bain

Job description

Location: Waukegan, IL

Contract Length: 6 Months with possible extension

Pay Rate: $35-38/hr

Individual is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.

This position will also ensure proper communication with all key partners in the functional departments in support of regulatory filings.

Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non-IT business applications and disciplines.

Manage/direct all facets of single or multiple, multidimensional, mission-critical projects through the Full Project Life Cycle.

Job Requirements:

  • Required Education: Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
  • Required Experience: 2+ years experience in CMC environment
  • Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)


  • 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 under pressure and manage multiple projects simultaneously
  • Detail/accuracy oriented
  • Collaborative and willing to learn
  • Familiarity with US and other international regulatory requirements for drug product dossiers
  • Manage, compile, and author CMC sections of marketed product variations with minimal management oversight.
  • Update simple CMC documents independently.
  • Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
  • Independently run reviews meetings.
  • Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.
  • Timely communication of systems issues to management.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.