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Regulatory Affairs Manager II

Oakbrook, MA 60523

Posted: 04/16/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 603392 Is job remote?: Yes Country: United States

Job Description

Pay is commiserate with experience and ranges between $58-63/hr
  • Performs eCTD submission management across the product portfolio to global Health Authorities for both major submissions and lifecycle management.
  • The Global Delivery Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products.
  • Oversee outsourced publishing deliverables on a day to day basis to ensure successful execution of operational activities for assigned products.
  • Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. Partners with planning and tracking to ensure submission deliverables are incorporated and visible to all stakeholders.
  • Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality.
  • Drives deliverable timelines with RSM and authoring community and sets appropriate standards and expectations of quality. Identifies and assesses impact of agency guidance updates relevant to submission sciences, and drives innovative process change for improved efficiency.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.