Planet Pharma
Overview
Regulatory Affairs Associate I role at Planet Pharma Target PR Range: 28-38/hr. Based on experience. Responsibilities
Manage, compile, and author CMC sections of marketed product variations, including CTD content; ensure structural and formatting requirements are met for assigned projects with minimal management oversight. Coordinate activities with all functional departments in support of regulatory filings. Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Independently facilitate project team meetings. Demonstrate superior oral and written communication skills; work cooperatively with all levels and types of global personnel. Experience working with electronic document management systems. Ability to work independently and manage multiple projects simultaneously; stay attuned to shifts in project scope and adjust priorities accordingly. Detail- and accuracy-oriented, collaborative, and willing to learn; familiarity with US and international regulatory requirements for dossiers. Qualifications
Minimum of a BA/BS Degree in Chemical and/or Biological Sciences or relevant discipline. Required Experience: 1-2 years pharmaceutical; 1-2 years cross-functional project management. Preferred Experience: 1-2 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3). Additional Information
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Get notified about new Regulatory Affairs Associate jobs in North Chicago, IL.
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Regulatory Affairs Associate I role at Planet Pharma Target PR Range: 28-38/hr. Based on experience. Responsibilities
Manage, compile, and author CMC sections of marketed product variations, including CTD content; ensure structural and formatting requirements are met for assigned projects with minimal management oversight. Coordinate activities with all functional departments in support of regulatory filings. Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Independently facilitate project team meetings. Demonstrate superior oral and written communication skills; work cooperatively with all levels and types of global personnel. Experience working with electronic document management systems. Ability to work independently and manage multiple projects simultaneously; stay attuned to shifts in project scope and adjust priorities accordingly. Detail- and accuracy-oriented, collaborative, and willing to learn; familiarity with US and international regulatory requirements for dossiers. Qualifications
Minimum of a BA/BS Degree in Chemical and/or Biological Sciences or relevant discipline. Required Experience: 1-2 years pharmaceutical; 1-2 years cross-functional project management. Preferred Experience: 1-2 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3). Additional Information
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Get notified about new Regulatory Affairs Associate jobs in North Chicago, IL.
#J-18808-Ljbffr