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Associate Director, Regulatory Affairs – CMC & Vaccines

REF: 1044

We have an exciting contract opportunity to join a growing team of consultants in North America.

We are looking for experienced RA professionals with experience in leading vaccine product portfolios.  Our client is a Top 10 Biopharma working in a long term partnership with G&L to support their CMC function.

Project responsibilities:

  • Ensure all regulatory activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
  • Manage and contribute to CMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
  • Serve as CMC representative on a core project(s), demonstrating the ability to manage project activities, assess regulatory risks & develop plans to develop global regulatory strategies for programs by regulatory, scientific & technical criteria.
  • Manage regulatory issues, maintain submission information in relevant systems, track regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
  • Serve as a technical and scientific resource within own workgroup/discipline and guide completion of difficult and complex projects.
  • Ensure 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 the company’s regulatory success.

Qualifications:

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

Technical experience:

  • Technical discipline with 8+ 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.
  • Demonstrated ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
  • Ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
  • Product release system exposure helpful.
  • Managing colleagues within a GCMC function, only if the position requires supervision of personnel.
  • 3+ years’ management & supervisory experience with technical projects &/or staff.
  • Contract Type:

    Contract opportunity

  • Location:

    US based, remote working

  • Duration:

    12 months+

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