Regulatory Affairs Associate I # 26-15292

Responsibilities Individual is responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will coordinate activities with all functional departments in support of regulatory filings. Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight. Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. 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. 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. Qualifications Minimum of a BA/BS Degree in Chemical, and/or Biological Sciences/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). Note Hybrid: Tues - Thurs onsite. About the Role Duration: 12 Months contract. Note: This description reflects the responsibilities and qualifications for the role. It does not constitute a job posting or guarantee of employment. Equal opportunity employer information may be included in other sections of the posting. #J-18808-Ljbffr US Tech Solutions