Regulatory Affairs Associate
JOB DESCRIPTION
Responsible for compliance with applicable procedures. This position will play a key role in preparing US and international regulatory filings. Individual coordinates and supports technical and scientific regulatory activities, researches regulations and guidelines, and maintains and organizes key information sources. Individual works under general supervision, receives limited supervision on standard issues, and detailed instruction on new assignments.
Job description may include:
Responsibilities
- Assist in the preparation of routine reports and regulatory agency communications
- Support the preparation and filings of INDs and CTAs
- Coordinate and organize materials in the preparation, review and filing of global license applications
- Update and maintain paper/electronic document archival systems
- Coordinate with external vendors for project support activities
- Track the committed timeliness and follow up with the internal departments proactively for required documents
- Assists in responding to regulatory information requests
- Oversee quality control of regulatory documents and submissions
- Assist with country specific regulatory support
- Assist with internal audits and inspections
- Other duties as assigned
Minimum Education, Qualifications:
Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), or medical fields preferred.
Skills:
Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required.
Ability to maintain a high level of accuracy and attention to detail, while maintaining deadlines for assigned projects.
Capable of working with an interdisciplinary team.
Minimum Experience:
1+ year experience in a registered industry (e.g. medical products, pharma, etc) preferred. Regulatory area is preferred but may consider quality assurance, research and development, scientific affairs or related area.
About LSKB
LSKB is a privately-held biopharmaceutical company with offices in Utah, California, and South Korea. LSKB specializes in clinical development of promising targeted therapies for unmet medical needs in cancer. LSKB’s lead proprietary drug candidates is rivoceranib, a selective VEGFR-2 inhibitor which has demonstrated clinical efficacy in a variety of solid tumors. LSKB can be found on the web at www.lskbiopharma.com .
