Spectraforce Technologies
Job Title:
Regulatory Affairs Associate Duration:
06 Months (Potential Extension) Location:
Hybrid in Lake County, IL 60064 Experience Level:
3-5 Years Responsibilities
Manage and compile CMC sections for marketed product variations, including CTD content, structural and formatting requirements. Coordinate activities with all functional departments to support regulatory filings. Ensure timely preparation of submission documents and maintain thoroughness, accuracy, and timeliness of CMC dossiers and responses. Independently facilitate project team meetings. Coordinate project timelines and deliverables, managing multiple projects simultaneously. Stay attentive to shifts in project scope and adjust priorities and strategies accordingly. Partner with RA CMC Project Leads to 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 and review/approve engineering study protocols, validation study protocols, and manufacturing changes for Class III implantable medical devices. File necessary applications and handle government interactions, including authoring and submitting PMA supplements (30‑Day Notice, Real‑Time Reviews, 180‑Day Supplements, Annual Reports). Maintain awareness of regulatory business systems, current best practices, and regulatory requirements for dossiers. Qualifications
BA/BS degree in Chemical, Biological Sciences, or a relevant discipline. 1‑2 years of experience in the pharmaceutical industry. 1‑2 years of cross‑functional project management experience. Preferred 1‑2 years in regulatory affairs, R&D, or manufacturing (CTD Module 3). Experience with electronic document management systems. Strong oral and written communication skills. Ability to work independently, manage multiple projects, and collaborate with all levels and types of global personnel. Detail/accuracy‑oriented, collaborative, and willing to learn. Familiarity with U.S. and other international regulatory requirements for dossiers. Preferred advanced degree and 1‑3 years of direct experience in the field of Class III implantable medical devices; proven track record of authoring, submitting, and approving Class III PMA supplements.
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Regulatory Affairs Associate Duration:
06 Months (Potential Extension) Location:
Hybrid in Lake County, IL 60064 Experience Level:
3-5 Years Responsibilities
Manage and compile CMC sections for marketed product variations, including CTD content, structural and formatting requirements. Coordinate activities with all functional departments to support regulatory filings. Ensure timely preparation of submission documents and maintain thoroughness, accuracy, and timeliness of CMC dossiers and responses. Independently facilitate project team meetings. Coordinate project timelines and deliverables, managing multiple projects simultaneously. Stay attentive to shifts in project scope and adjust priorities and strategies accordingly. Partner with RA CMC Project Leads to 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 and review/approve engineering study protocols, validation study protocols, and manufacturing changes for Class III implantable medical devices. File necessary applications and handle government interactions, including authoring and submitting PMA supplements (30‑Day Notice, Real‑Time Reviews, 180‑Day Supplements, Annual Reports). Maintain awareness of regulatory business systems, current best practices, and regulatory requirements for dossiers. Qualifications
BA/BS degree in Chemical, Biological Sciences, or a relevant discipline. 1‑2 years of experience in the pharmaceutical industry. 1‑2 years of cross‑functional project management experience. Preferred 1‑2 years in regulatory affairs, R&D, or manufacturing (CTD Module 3). Experience with electronic document management systems. Strong oral and written communication skills. Ability to work independently, manage multiple projects, and collaborate with all levels and types of global personnel. Detail/accuracy‑oriented, collaborative, and willing to learn. Familiarity with U.S. and other international regulatory requirements for dossiers. Preferred advanced degree and 1‑3 years of direct experience in the field of Class III implantable medical devices; proven track record of authoring, submitting, and approving Class III PMA supplements.
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