Regulatory Affairs Associate

Regulatory Affairs Associate – Katalyst CRO

Location: Miami, FL (Also Miramar, FL and Miami‑Fort Lauderdale Area)

Salary: $58,000 – $75,000 per year.

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.
• Conduct review meetings for submission documents.
• Understand CMC expectations, including CTD content, structural and formatting requirements.
• Maintain awareness of and utilize current best practices for regulatory business systems within the group.
• Author and submit PMA supplements (30‑day Notice, Real‑Time Reviews, 180‑Day Supplements, Annual Reports).
• Review/approve engineering study protocols/reports and validation study protocols/reports.
• Review and approve manufacturing changes for Class III implantable medical devices.
• Manage and author CMC sections of marketed product variations, ensuring CTD content, structural and formatting requirements are met for assigned projects with minimal management oversight.
• 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 and 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, Biological Sciences, or relevant discipline.
• 4 years pharmaceutical experience, including 1‑2 years in regulatory affairs, R&D, or manufacturing (CTD Module 3).
• 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 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.

Seniority Level

Mid‑Senior level

Employment Type

Contract

Job Function

Legal

Industries

Pharmaceutical Manufacturing

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