Planet Pharma Cambridge , MA 02138
Management and conduct of the Global regulatory activities for assigned projects in line with regulatory requirements.
Provide Global Regulatory Strategy support as needed on development and marketed products. This support will include both strategic and operational activities.
Preparing, compiling, reviewing and processing the regulatory submissions including both pre-approval and submissions such as IND, NDA/BLA, MAA, amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, etc.
Coordinating and consulting with other concerned functions on the content,and assembly of regulatory documentation and ensuring consistency, completeness and adherence to standards for all the regulatory submissions.
Attending and participating in the assigned project/regulatory product development and submission teams, providing clear and consistent regulatory recommendations.
Assist with regulatory communications with the FDA for assigned products and activities, including preparing the FDA meeting requests, briefing book, meeting rehearsals/slides, meeting minutes of the FDA meetings and the generation of responses to the FDA queries.
Support the compilation, development, submission, and maintenance of worldwide regulatory filings;
Track regulatory project status and informational documents
Coordinate required documentation in coordination with CMC Team or Functional group
Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time
Interfacing with global Regulatory partners and internal cross functional teams
Attending relevant functional area and project team meetings as required