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Manager, Regulatory Affairs – CMC

We have multiple openings to join G&L’s Regulatory team in North America.  You would be joining a large team of industry-leading RA consultants, assigned to client engagements with a CMC and vaccine focus.

Project responsibilities will include:

  • Develop effective relationships with local & global client stakeholders
  • Ensure all regulatory activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
  • Contribute to CMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
  • Demonstrate ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
  • Serve as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
  • Manage regulatory issues, maintain submission information in relevant systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
  • Serves as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects.
  • Providing guidance & direction for direct reports, managing global resources & resource capacity along with prioritizing workload appropriately.
  • Ensuring all regulatory activities within the team are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
  • Develop relationships with regulatory authorities to improve companies regulatory success
  • May participate in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to GCMC functions.
  • Serve as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to contribute to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
  • Demonstrate ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.

Education:

  • Bachelor’s degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.

Previous experience should include:

  • Technical discipline with 6+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 3+ years pharmaceutical regulatory experience.
  • Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.
  • Experience operating within GMP, GLP, or GCP related SOPs.
  • Product release system exposure helpful
  • Managing colleagues within a GCMC function, only if the position requires supervision of personnel.
  • 2+ years’ management & supervisory experience with technical project and/or staff.
  • Conformance/Quality experience in pharmaceutical or other regulated industry is strongly desired.
  • Experience with CMC regulatory submissions, process development and/or GMP manufacture of clinical and/or commercial products.
  • Strong understanding of CMC change management processes and CMC CTD content/structure.
  • Advanced skills in written & oral communications are mandatory.
  • Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
  • Skills in document manipulation and electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools
  • Prior experience managing projects is preferred.
  • Lean and/or SixSigma experience helpful.
  • Contract Type:

    Permanent career opportunity

  • Location:

    US based, remote working

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