Regulatory Affairs Specialist - CMC Post-Approval

Location: Waukegan, IL

Contract Length: 6 Months (with possible extensions)

Pay Rate: $32-37/hr

Position Overview:

We are looking for an experienced Regulatory Affairs Specialist with a strong background in RA-CMC post-approval changes. This position will primarily focus on the authoring of content changes and compilation of CMC sections for regulatory submissions. The ideal candidate will have in-depth knowledge of CMC Module 3.

Key Responsibilities:

• Manage, compile, and author CMC sections of marketed product variations with minimal management oversight.
• Update CMC documents independently.
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
• Prepare and maintain CMC Module 3 documentation to meet regulatory requirements.
• Collaborate with cross-functional teams to gather and organize necessary CMC data.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.
• Stay current with regulatory guidelines and requirements related to CMC post-approval changes.

Qualifications/Experience:

Required Experience: 5 years pharmaceutical experience including 2+ years in CMC Regulatory Affairs including experience with CTD Module 3

• 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
• Familiarity with US and other international regulatory requirements for drug product dossiers

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.