Regulatory Affairs - Executive/Assistant Manager/Deputy Manager/Manager

Authoring / writing and review of CMC sections of dossier Critical review of design stage documents (specifications, controls and protocols) to ensure that regulatory requirements are fulfilled Assessment of change controls to evaluate the regulatory impact and to strategize the post approval submissions Co-ordination for collection of post-execution data from various functions and review for compliance against the design specifications, controls and protocols. Collaboration with various cross functional team members for timely conclusion of action items identified for responding deficiencies. Review and to check the accuracy of information in various status and database maintained at department / organization level Ensure compliance of regulatory submissions with current regulations and guidance In depth understanding of regulatory requirements and Health Agency’sexpectations Contributes individually or manage the team / subordinates effectively to ensure that target submissions are achieved in time Train and develop individuals to achieve department and organization goals Show more Show less