Job TitleTop Skills:Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies.Technical writing skillsFamiliar with typical manufacturing processes, especially cell culturesFamiliar with microbial methodologyFamiliar with ICH and country regulatory procedures for clinical trialsAble to work with electronic systems i.e., Microsoft and dossier publication systemsResponsibilities:Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).Review/approval of engineering study protocols/reports and validation study protocols/reports.Review and approval of manufacturing changes for Class III implantable medical devices.May require an advanced degree and 3 to 5 years of direct experience in the field.Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable 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.May lead and direct the work of others.A wide degree of creativity and latitude is expected.Requirements:CMC (Chemistry, Manufacturing, Controls) background in completing clinical submissionsIND/IMPD submission background based on manufacturing batch recordsEarly Phase CMC knowledge a plusFrench/ English speaking a plusExperience Level = 3-5 Years