Huya Bioscience International
Del Mar, CA
General Job Description:
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.
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.
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
Application Information & Contact (How to Apply)
Interested candidates should submit resumes to: email@example.com.