Regulatory Affairs Manager

Location
San Diego, CA
Posted
Jul 21, 2021
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

HUYABIO International, LLC is a biopharmaceutical company focused on globalizing products from China and Asia for the world markets in multiple therapeutic areas. The Company’s lead compound in oncology, which is approved for lymphoma in China, is in late-stage clinical development in Japan and Korea. In the United States, the compound is being developed in immune oncology (IO) in multiple tumor types and disease settings. HUYABIO has a pipeline of IO compounds as well as other compounds for cardiovascular diseases. More information can be found at www.huyabio.com

Job Summary

The Regulatory Manager will oversee the day-to-day regulatory information management activities including the operations/submissions function for projects at HUYABIO.  Will ensure the company is adhering to applicable government requirements 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 HUYABIO 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 Regulatory Information Systems
  • 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 to HUYABIO standards 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 corporate and department goals
  • Strong verbal and written communication skills
  • Strong knowledge of current US and ex-US regulatory guidelines (e.g., PMDA, EMA, MHRA, HC) including GMP, GCP and GLP (GXP) requirements
  • Knowledge of Regulatory Information systems
  • Knowledge of eCTD requirements
  • Ability to work well in a fast-paced 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

The position is full‐time and the candidate must be within commuting distance to HUYABIO’s Del Mar, CA headquarters.