The Regulatory Affairs Specialist is an integral role that will contribute to the successful achievement of product development objectives by assisting with the preparation and coordination of documents in support of local and international regulatory submissions. The incumbent will provide administrative support, assistance with tracking and related data, and will assist in all regulatory affairs-related tasks.
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:
- Responsible for preparing and submitting regulatory documents for investigational and commercial biologics and small molecule products; documents may include cover letters, INDs, NDAs, BLAs, amendments, supplements, annual reports, etc.
- Perform document filing and retrieval as directed or in conjunction with departmental SOPs and work instructions.
- Coordinate activities with the cross-functional team members for regulatory activities.
- Assist regulatory team members with their submissions and tracking of regulatory activities.
- Assist in developing and maintaining procedures for regulatory operations.
- Analyze and make recommendations on submissions as necessary.
- Maintain knowledge of regulatory requirements and communicate changes in regulatory information to the regulatory project teams in a timely manner.
- Work with local, regional, and international regulatory sites to support the accurate and timely communication of critical information.
- Perform other duties as required.
Job Qualifications and Requirements:
- Minimum of one (1) year of experience in regulatory affairs coordination and/or administrative experience within similar biotech, pharmaceutical, CRO, or academic institution.
- Bachelor’s degree preferred, but not required.
- Experience in formulating, writing, reviewing, and/or editing comprehensive regulatory documents for submission.
- Experience in proactively identifying necessary submission content and assessing the project documentation.
- Working knowledge of clinical research and data analysis is required.
- Working knowledge of FDA and/or international regulations as it pertains to the successful development of pharmaceutical drugs.
- Good communication oral, written, and interpersonal skills.
- Good organizational skills.
- Must work well under demanding deadlines and have excellent attention to detail.
- Ability to interact effectively with many diverse functional groups.
To learn more about HUYABIO International, please visit www.huyabio.com. HUYABIO is an equal opportunity employer.