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Clinical Operations and Regulatory Affairs, Shanghai | 4 Oct 2021

Senior Director / Executive Director, Formulation Development

Job Title: Senior Director / Executive Director, Formulation Development
Location: Shanghai

 

Responsibilities

  • Supervise and support formulation development team to develop, optimize, scale-up, and manufacture CTM in support of IND, early and late stage clinical studies.
  • Work with pre-clinical and CMC teams to characterize candidate compounds through pre-formulation studies and to develop toxicological formulations and clinical formulations for IND submission and first-in-human trials.
  • Develop dissolution strategy to support formulation screening and optimization. Evaluate enabling technologies for commercial dosage form.
  • Work with CMOs or commercial plant to assist gap analysis, risk assessment, tech transfer, process DOE and optimization.
  • Coordinate with external collaborators including international Pharmaceutical companies to co-develop formulations and to overlook the projects’ progress.
  • Evaluate and manage CMOs to ensure timely delivery of CTMs with high quality.
  • Draft and review regulatory filing documents of IND and NDA for NMPA, FDA, EMA and TGA, etc.
  • Prepare and participate interactive technical meetings with external collaborators and official reviewers in CDE.
  • Collaborate with other functional groups in pharmaceutical development, regulatory affairs, and clinical supply operation and contractors.

 

Requirements

  • Ph.D in pharmaceutical science or related fields.
  • Over 10 years’ experience in formulation or drug product development. Overseas working experience in global pharmaceutical company is preferred.
  • Familiar with pharmaceutical industry regulations such as ICH, NMPA and FDA guidance etc. IND and NDA experience for FDA or EMA is preferred.
  • Excellent leadership and management skills, including supervision and mentoring of teams. Good communication and positive interpersonal skills.

 
If interested, please forward your resume to yvonnew@hutch-med.com