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Regulatory Affairs Associate II

North Chicago, IL 60048

Posted: 02/07/2025 Employment Type: Contract Job Category: Regulatory Affairs Job Number: 617374 Is job remote?: Yes Country: United States

Job Description

Target PR Range: 22-32/hr
*Depending on experience

- Bachelors Degree: Science
- Regulatory submission documentation creation background

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)

RA Associate
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. Skills for running review meetings for submission documents. Understand CMC expectations including CTD content, structural and formatting requirements. Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.

*CO/NYC candidates might not be considered
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About North Chicago, IL

Ready to take the next step in your career? Explore job opportunities in and around North Chicago, Illinois, where growth knows no bounds. Nestled along the shores of Lake Michigan, this vibrant area offers a blend of urban excitement and natural beauty. Home to iconic landmarks like Navy Pier and the Art Institute of Chicago, plus renowned theater venues like the Chicago Shakespeare Theater and iconic sports teams like the Cubs and Bulls, North Chicago boasts a rich cultural tapestry. Indulge in the local deep-dish pizza or take a stroll through Millennium Park; this region truly has something for everyone. Join us in discovering the endless possibilities for personal and professional growth in North Chicago - where careers flourish and dreams take flight.

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