Vacancy Description
Top Skills:
Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies.
Technical writing skills
Familiar with typical manufacturing processes, especially cell cultures
Familiar with microbial methodology
Familiar with ICH and country regulatory procedures for clinical trials
Able to work with electronic systems , Microsoft and dossier publication systems Responsibilities: 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 (-day Notice, Real-Time Reviews, -Day Supplements, Annual Reports).
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class...