Regulatory Affairs Associate
Katalyst CRO, Miami, FL, United States
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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– 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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