Regulatory Affairs Associate

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

Responsibilities

• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• 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.
• 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.
• Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class III implantable medical devices.
• 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.

Responsibilities

• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• 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.
• 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.
• Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class III implantable medical devices.
• 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.

Requirements

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
• 4 years pharmaceutical. 1-2 years cross functional project management
• 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
• May require an advanced degree and 3 to 5 years of direct experience in the field.
• Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
• Relies on extensive experience and judgment to plan and accomplish goals.
• Performs a variety of tasks.