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Job Details

Location
Boston
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-173607
Contact
Richard Hao
Posted
about 3 years ago
  • Well-known Listed Pharmaceutical Group, global business is rapidly expanding
  • Dynamic international working environment, bottom-up culture
  • A fast-moving opportunity on career path and fair internal promotion mechanism

 
The Role:

Our client is a world leading listed pharmaceutical group, CRO is their innovation business worldwide. They are proud of the strides that we have made since our founding in 1999, providing R&D and one-stop production services to the world’s top pharmaceutical companies. Driving our success is our commitment to continual optimization and investing in the future. By improving the capabilities our partners need now, and maintaining the agility needed to support innovation, we’ve built a knowledge and experience base that we’re ready to share.

Whether we’re supporting emerging biotech companies or smaller, specialty pharma, our mission remains to accelerate the launch of new drugs, providing one-stop CMC services for the full lifecycle of drug development.

Requirements

Line Manager: US Head and dotted line to Function Leader

Job Responsibility Summary：
  • The Director of Regulatory Affairs is responsible for the regulatory oversight of nonclinical and clinical programs across therapeutic areas and modalities for Clin-nov Medical in the United States and ex US as appropriate.
  • This position will report to the US Head, Clin-nov and dotted line to the leader of RA Department.

Job Responsibilities：
  • Development and implementation of non-clinical and clinical regulatory strategies and tactics (pre- and post-approval), meeting regulatory requirements including, but not limited to INDs, NDAs 505(b)(1), NDAs 505(b)(2), ANDAs, BLAs.
  • Review and regulatory assessment of study documents, including but not limited to protocols, amendment, Case Report Forms, consent documents, Institutional Review Board submissions, study reports, monitoring plans, etc.
  • Preparation or review, and finalization of non-clinical/clinical regulatory submissions dossier in compliance with appropriate regulations and guidelines.
  • Develop collaborative and respectful relationships with internal and external customers, ensuring activities are performed according to regulatory strategies and assisting with regulatory questions.
  • Interaction and regulatory oversight of GLP laboratory and CRO activities related to non-clinical/clinical studies on behalf of the sponsor.
  • Regulatory review, assessment, and approval of non-clinical/clinical change controls.
  • Assessment and regulatory oversight of non-clinical/clinical functions in compliance with all appropriate regulations and guidelines.
  • Direct interaction and liaison with regulatory agencies as required.

Job Requirements：

Education/Experience：
  • Minimum of 10 years of industry experience; minimum of 5 years clinical regulatory experience with extensive knowledge and experience of US regulations and GLP and GCP guidelines.
  • Minimum Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
  • Previous experience in leading global health authority interactions.
  • Solid knowledge of regulatory affairs in multiple therapeutic areas including oncology in early and late development.

BeathChapman Pte Ltd