Regulatory Affairs Associate — CMC & PMA Expert

Katalyst CRO; Miami (FL); On-site; USD 90,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a regulatory affairs professional to manage CMC dossiers, coordinate PMA submissions, and oversee CTD content for Class III implantable devices. This role requires collaboration with global teams and extensive experience with regulatory submissions.

You will lead complex documentation efforts, ensure compliance with US FDA PMA guidance, and drive project timelines across multiple initiatives.

Qualifications

• BA/BS in Chemical or Biological Sciences or related discipline.
• 4 years of pharmaceutical work; 1–2 years in cross-functional PM and regulatory affairs.
• Experience with CTD Module 3 and PMA supplements preferred.

Responsibilities

• Manage projects to ensure thorough, accurate, and timely CMC dossiers and responses.
• Filing applications and handling government interactions for regulatory approvals.
• Compile CMC sections for marketed product variations (CTD content).
• Collaborate with RA CMC leads to develop module 3 content and timelines.
• Lead review meetings and ensure regulatory file-ability and acceptance.
• Author and submit PMA supplements (30-day notices, 180-day reviews, annual reports).
• Review engineering and validation study protocols/reports; approve manufacturing changes for Class III devices.
• Independently facilitate project team meetings and manage multiple projects.

Skills

CMC Dossier Management

Regulatory Submissions

PMA Submissions

CTD Content Knowledge

Independent Project Management

US FDA PMA Guidance

Electronic Document Management

Regulatory Requirements Knowledge

Cross-Functional Collaboration

Communication Skills

Education

BA/BS in Chemical or Biological Sciences

4–5 years pharmaceutical experience

1–2 years regulatory affairs/ manufacturing (CTD Module 3)

Advanced degree (may be required)

Tools

Electronic Document Management Systems

Job description

Katalyst CRO is seeking a regulatory affairs professional to manage CMC dossiers, coordinate PMA submissions, and oversee CTD content for Class III implantable devices. This role requires collaboration with global teams and extensive experience with regulatory submissions.

You will lead complex documentation efforts, ensure compliance with US FDA PMA guidance, and drive project timelines across multiple initiatives.