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Regulatory Affairs Specialist III

Expired Job

Planet Pharma Cambridge , MA 02138

Posted 4 months ago

Service:

Management and conduct of the Global regulatory activities for assigned projects in line with regulatory requirements.

PRIMARY RESPONSIBILITIES:

  • 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

Skills:

  • NDA, BLA/IND/CTA experience

Education:

  • BS minimum, Master of Science preferred

Type:Temp/ContractLocation:Cambridge, MA


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Regulatory Affairs Specialist III

Expired Job

Planet Pharma