Regulatory Affairs Associate - CMC & eCTD Specialist

The Fountain Group; North Chicago (IL); On-site; USD 85,000 - 125,000; Full time

Job summary

The Fountain Group is seeking a technical project manager to oversee activities for marketed product variations, including authoring and compiling CMC sections for regulatory submissions. You will coordinate with RA CMC Leads and diverse functional groups to ensure file-ability and timely delivery of CTD content with minimal oversight.

Role requires 1–2 years in pharma, strong communication, and ability to manage multiple projects.

Qualifications

• BA/BS in Chemical or Biological Sciences or related field required.
• 1–3 years pharmaceutical experience; regulatory affairs/ R&D or Manufacturing exposure helpful.
• Experience managing CMC sections and module 3 content for regulatory submissions.

Responsibilities

• Manage activities for marketed product variations and author/compile CMC content for CTD submissions.
• Coordinate with RA CMC Lead and cross-functional teams to ensure file-ability and timely responses.
• Facilitate project team meetings and maintain timelines for regulatory filings.
• Ensure proper structural/formatting of CMC dossiers and responses.
• Liaise with internal stakeholders to align on scope, objectives, and regulatory requirements.
• Maintain awareness of current best practices for regulatory document systems.

Skills

CMC knowledge

Project management

Regulatory coordination

Cross-functional collaboration

Communication

Education

BA/BS in Chemical or Biological Sciences

Tools

Electronic document management systems

Job description

The Fountain Group is seeking a technical project manager to oversee activities for marketed product variations, including authoring and compiling CMC sections for regulatory submissions. You will coordinate with RA CMC Leads and diverse functional groups to ensure file-ability and timely delivery of CTD content with minimal oversight.

Role requires 1–2 years in pharma, strong communication, and ability to manage multiple projects.