Katalyst CRO
Piscataway, NJ • $83,200.00‑$117,500.00 • 1 week ago
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.
Run review meetings for submission documents.
Understand CMC expectations including CTD content, structural and formatting requirements.
Maintain awareness of and utilize current best practices for the use of regulatory business systems within the group.
Author and submit PMA supplements (30‑day Notice, Real‑Time Reviews, 180‑Day Supplements, Annual Reports).
Review and approve engineering study protocols/reports and validation study protocols/reports.
Review and approve manufacturing changes for Class III implantable medical devices.
Manage, compile, and author CMC sections of marketed product variations, ensuring CTD content, structural and formatting requirements are met with minimal management oversight.
Independently facilitate project team meetings.
Exhibit superior oral and written communication skills.
Work cooperatively with all levels and types of global personnel.
Use electronic document management systems effectively.
Work independently and manage multiple projects simultaneously.
Adjust priorities and strategies as necessary by staying attuned to shifts in project scope and business objectives.
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 a relevant discipline.
4 years pharmaceutical experience; 1–2 years in 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 3–5 years of direct experience in the field.
Recent experience with Class III implantable medical devices; proven track record of authoring, submitting, and obtaining approval of Class III 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.
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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.
Run review meetings for submission documents.
Understand CMC expectations including CTD content, structural and formatting requirements.
Maintain awareness of and utilize current best practices for the use of regulatory business systems within the group.
Author and submit PMA supplements (30‑day Notice, Real‑Time Reviews, 180‑Day Supplements, Annual Reports).
Review and approve engineering study protocols/reports and validation study protocols/reports.
Review and approve manufacturing changes for Class III implantable medical devices.
Manage, compile, and author CMC sections of marketed product variations, ensuring CTD content, structural and formatting requirements are met with minimal management oversight.
Independently facilitate project team meetings.
Exhibit superior oral and written communication skills.
Work cooperatively with all levels and types of global personnel.
Use electronic document management systems effectively.
Work independently and manage multiple projects simultaneously.
Adjust priorities and strategies as necessary by staying attuned to shifts in project scope and business objectives.
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 a relevant discipline.
4 years pharmaceutical experience; 1–2 years in 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 3–5 years of direct experience in the field.
Recent experience with Class III implantable medical devices; proven track record of authoring, submitting, and obtaining approval of Class III 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.
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