Associate Director Regulatory Affairs Consultant

Associate Director Regulatory Affairs Consultant

My client is seeking a highly motivated, science driven, experienced consultant to join their collaborative, rapidly growing biotech company. They are one of the few organizations who are leading novel vaccine development to treat millions of patients world-wide. The Associate Director of Regulatory Affairs will be responsible for the preparation and management of simple and complex regulatory submissions. You will act as liaison between Regulatory Affairs and other functional areas on various projects. The successful professional operates with a high level of enthusiasm, energy, and integrity.

 

Responsibilities:

  • Responsible for managing regulatory compliance, identifying regulatory issues relevant to products in development and providing accurate and timely recommendations to management and project teams
  • Represent regulatory affairs in cross-functional team meetings, including product development teams
  • Actively contribute to the clinical and implementation of regulatory strategy for assigned projects
  • Accountable for preparing, coordinating, and managing various regulatory submissions
  • Provide regulatory support for clinical operations activities

 

Knowledge and Skills:

  • Minimum BA in a scientific degree required; advanced degree preferred
  • Minimum of 7 years’ regulatory experience in a pharmaceutical/biologics company
  • Knowledge of all FDA requirements pertaining to the control and submission of regulatory documents for biologics/drug approval
  • Solid understanding of FDA regulations and ICH guidance’s and experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format

 

Number of hours worked per week: 25-35 hours a week (on-site)

Length of Assignment: 6 months with the possibility of extension

Position Location: Cambridge, MA

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