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E: hello@gandlscientific.com
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E: hello@gandlscientific.com

Associate Director, Regulatory Affairs – CMC & Vaccines

We have multiple career opportunities to join G&L’s core team of consultants in North America. We are looking for progressive and collaborative team members to work on a long term client engagement.  The details of the client project are detailed below – but your role as a consultant may be varied and busy!

The location of these new headcounts can be very flexible and can be based anywhere, although we have offices in New Jersey, Florida, LA, San Diego and Boston.

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.
  • Demonstrated 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.
  • Serve as a technical and scientific resource within own work group/discipline and provides guidance for 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 companies regulatory success
  • 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.

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.
  • 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:

    Permanent career opportunity

  • Location:

    US remote working

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