MedStar Health
Position Title:
Regulatory Affairs Associate Work Location:
North Chicago IL 60064 (Hybrid) Assignment Duration:
12 Months The individual is responsible for managing activities related to marketed product variations, including authoring and compiling chemistry, manufacturing, and control (CMC) sections to ensure the timely preparation of submission documents. This position will coordinate activities with all functional departments to support regulatory filings. Manage, compile, and author CMC sections of marketed product variations, including CTD content, ensuring structural and formatting requirements are met with minimal management oversight. Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Facilitate project team meetings independently. Demonstrate superior oral and written communication skills. Work cooperatively with all levels and types of global personnel. Experience with electronic document management systems. Work independently, managing multiple projects simultaneously. Adjust priorities and strategies based on project scope, business objectives, and team feedback. Be detail-oriented, collaborative, and willing to learn. Familiarity with US and international regulatory requirements for dossiers. Minimum of a BA/BS Degree in Chemical, Biological Sciences, or relevant discipline. Required Experience: 4 years in pharmaceuticals, including 1-2 years in cross-functional project management. Preferred Experience: 5 years in pharmaceuticals, including 1-2 years in regulatory affairs, R&D, or manufacturing (CTD Module 3).
Additional responsibilities include managing and compiling CMC sections of marketed product variations, partnering with RA CMC Project Leads, and developing module 3 content and project timelines. Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections. Maintain awareness of and utilize current best practices in regulatory business systems. Further responsibilities encompass filing applications, handling government interactions for products requiring approval, authoring and submitting PMA supplements, reviewing/approving engineering and validation study protocols/reports, and reviewing manufacturing changes for Class III implantable medical devices. Requires an advanced degree and 3-5 years of direct experience, including recent experience with Class III implantable medical devices and successful submission/approval of PMA supplements. Knowledge of FDA PMA guidance documents and CFR regulations is essential. The role relies on extensive experience and judgment, may involve leading others, and demands creativity and latitude in task execution. #J-18808-Ljbffr
Regulatory Affairs Associate Work Location:
North Chicago IL 60064 (Hybrid) Assignment Duration:
12 Months The individual is responsible for managing activities related to marketed product variations, including authoring and compiling chemistry, manufacturing, and control (CMC) sections to ensure the timely preparation of submission documents. This position will coordinate activities with all functional departments to support regulatory filings. Manage, compile, and author CMC sections of marketed product variations, including CTD content, ensuring structural and formatting requirements are met with minimal management oversight. Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Facilitate project team meetings independently. Demonstrate superior oral and written communication skills. Work cooperatively with all levels and types of global personnel. Experience with electronic document management systems. Work independently, managing multiple projects simultaneously. Adjust priorities and strategies based on project scope, business objectives, and team feedback. Be detail-oriented, collaborative, and willing to learn. Familiarity with US and international regulatory requirements for dossiers. Minimum of a BA/BS Degree in Chemical, Biological Sciences, or relevant discipline. Required Experience: 4 years in pharmaceuticals, including 1-2 years in cross-functional project management. Preferred Experience: 5 years in pharmaceuticals, including 1-2 years in regulatory affairs, R&D, or manufacturing (CTD Module 3).
Additional responsibilities include managing and compiling CMC sections of marketed product variations, partnering with RA CMC Project Leads, and developing module 3 content and project timelines. Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections. Maintain awareness of and utilize current best practices in regulatory business systems. Further responsibilities encompass filing applications, handling government interactions for products requiring approval, authoring and submitting PMA supplements, reviewing/approving engineering and validation study protocols/reports, and reviewing manufacturing changes for Class III implantable medical devices. Requires an advanced degree and 3-5 years of direct experience, including recent experience with Class III implantable medical devices and successful submission/approval of PMA supplements. Knowledge of FDA PMA guidance documents and CFR regulations is essential. The role relies on extensive experience and judgment, may involve leading others, and demands creativity and latitude in task execution. #J-18808-Ljbffr