Regulatory Manager

Location
San Diego, California
Posted
Jun 08, 2018
Required Education
Bachelors Degree
Position Type
Full time

Come join our world-class team evaluating, in-licensing and developing innovative therapeutic products internationally.

HUYA Bioscience International is a development-stage biopharmaceutical company bringing innovations from China to global markets in multiple therapeutic areas. The Company’s lead cardiovascular program, HBI-3000, recently started a phase 1 in Europe and HUYA’s partner in China has run multiple phase 2 trials there. HUYA’s lead compound in oncology, HBI-8000, is in late stage clinical development in Japan and Korea for the treatment of hematological malignancies. In the United States, HBI-8000 is being developed in combination with immune checkpoint inhibitors in solid tumors. Two additional compounds are in early evaluation for oncology and cardiovascular diseases. More information can be found at www.huyabio.com

Job Summary

The Regulatory Manager will oversee the day to day regulatory operations/submissions function for one or more projects at HUYA.  Will ensure the company is adhering to all applicable government regulations and successfully manage multiple projects simultaneously while adapting to changing project priorities.

This is an office based position that works in a cross-functional and dynamic environment.  Clear, timely, professional, and effective communication with all HUYA functional areas and global office sites is essential.

Primary Duties and Responsibilities

  • Prepare information necessary for investigational, marketing, and/or post-licensure regulatory submissions (including INDs, IND amendments, annual reports, NDAs) in accordance with the regulations and relevant guidelines (domestic, national and international)
  • Manages updates to CMC, nonclinical, and clinical information included in regulatory submissions (e.g., IB, protocols, safety reports)
  • Assists other departments and submission authors in writing and editing submissions, in compliance with departmental and regulatory standards
  • Researches and provides analysis of current regulatory rules and guidance’s, as needed
  • Prepares and maintains submission tracking documents and monitors status of the submission components 
  • Review and edit documents, to ensure consistency and regulatory compliance
  • Create and manage departmental SOPs related to regulatory affairs and operations
  • Produce high quality regulatory submissions using electronic templates and publishing systems
  • Responsible for assigned activities with the project team
  • Perform other duties as required

Job Requirements

  • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals
  • Strong verbal and written communication skills
  • Strong knowledge of current US and ex-US regulatory guidelines (e.g., PMDA, MFDS, MHRA)
  • Ability to work well in a deadline-driven environment
  • Capable of supporting multiple projects simultaneously
  • Excellent computer skills
  • Travel as needed

Education and Experience

  • Bachelor’s degree Life/Health Sciences
  • Experience with electronic filing and database management abilities
  • Experience with documentation systems and with document review and auditing
  • Minimum of 5 years of experience in pharmaceutical / biotech