What are the responsibilities and job description for the CMC Regulatory Affairs Associate position at Orion Group?
Location: Waukegan, IL
Contract Length: through 2025 with potential for extension
Pay Rate: 30/hr including individual healthcare coverage
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
- Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
- Required Experience: 4 years pharmaceutical. 1-2 years cross functional project management
- Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
