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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior CMC Project Manager


Reference:SCANWB-172732 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: CMC Regulatory Affairs

Senior CMC Project Manager
Our client, a biopharmaceutical organisation based in Dublin, are currently recruiting for a Senior CMC Project Manager to join their team on a permanent basis. As Senior CMC Project Manager you will be responsible for the coordination of and the day-to-day management of CMC projects.

Responsibilities

  • Develop and execute the strategy for development and clinical study production of the organisations drug products in alignment with company goals and clinical plans
  • Oversee all CMC activities with vendors, relating to both drug substance, drug products, and devices
  • Develop and control appropriate budgets and timelines
  • Review and technically approval all analysis data, development reports and protocols, work orders and quotes related to CMC
  • Summarize and present CMC plans and activities to management
  • Responsible for providing CMC-related regulatory documents to authorities
  • Manage CROs, CMOs, scientific advisors & regulatory advisors
  • Manage and update the project and development plans assisting in the review of regulatory filings including IMPD and other specific CMC-related regulatory documents
  • Assist in defining regulatory strategies both towards FDA and EMA
  • Assist in coordinating the assembly of regulatory packages, both towards FDA and EMA
  • Assist in assembling and coordinate assembly of data packages for management reporting

Requirements

  • University Degree (e.g., graduate Biochemist, Biologist, pharmacist, chemist, engineer), preferably with a PhD
  • Minimum 3 to 5 years’ experience as a project manager in a pharmaceutical and/or biotech company or CRO
  • Experience with regulatory documentation for CMC activities on drug substance, drug product both towards FDA and EMA is mandatory
  • Experience working on CMC documentation for respiratory devices is preferred
  • Experience in the management of clinical trial production, labelling, shipment and clinical supplies coordination
  • Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines
  • Updated knowledge of ICH GMP is required
  • Excellent communication, presentation, and interpersonal skills
  • Self-driven and motivated team player
  • Familiar with working in a virtual setup
  • Fluent in written and spoken professional English