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Director of Regulatory Operations
Ref No.: 17-01661
Location: Lawrenceville, New Jersey
Position Type:Contract
Start Date / End Date: 12/18/2017 to 06/17/2018

Project Description:
  • Working with Client regulatory strategy and an external vendor of regulatory services, this role will ensure that appropriate regulatory processes for the management of regulatory dossiers, documents, and publishing are created, and documented.
  • Responsible for ensuring a common and simplified system of document creation, review and approval is in place sufficient to comply with regulatory standards.
  • Responsible for ensuring appropriate training of the relevant staff that are engaged in these processes.
  • Responsible for review and assessment of the processes with the existing SOPs and regulations.
  • Responsible for the review and editing of the documentation that explains the processes, ensuring clarity and appropriate detail.
  • Ensure that all processes are consistent with ensuring quality and appropriate quality control of the process outputs.
  • Oversees short and long term global dossier management strategies for all products/projects at all phases.
  • Recommends departmental process and policy through oversight, review, approval, implementation and maintenance of SOPs and work practices.
  • Ensures processes are in place to create dossiers on time and are of high quality, consistently meeting regulatory standards, and provides guidance to solve issues.
  • Constructively challenges decision making when necessary, based upon experience and Regulatory knowledge. Influences other functions as appropriate regarding business process.

Required Skills:
  • 10 years' experience in the management of regulatory operational work supporting new drug registration and application maintenance.
  • Thorough understanding of cross-functional operational aspects of dossier planning, preparation and management. In depth hands on experience in the planning, creating, and submission of regulatory dossiers in the US and outside the US.
  • Experience in creating, documenting and training on regulatory processes that underpin drug development, such as US FDA IND maintenance activities, safety data processing, regulatory submission management, medical writing, and regulatory document publishing.
  • Knowledge and Experience with the Regulatory guidelines, regulations and best practices for management of global regulatory operations.
  • Knowledge and experience in using electronic publishing systems required to create electronic regulatory submission, document and dossier management systems.
  • Demonstrates strong working knowledge of global regulatory practices and requirements.
  • Demonstrated ability to work with, influence, in a complex and culturally diverse, dynamic environment to deliver value-added results to the organization.
  • Demonstrated ability to work in an organized and consistent manner even under pressure.
  • Demonstrated ability to effectively communicate ideas and persuade others to accomplish challenging goals and objectives.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: