Regulatory Affairs Associate - I
199 East Blaine Street Seattle, WA 98102
Our client is an American biotechnology company that researches, develops and commercializes drugs.
- Provides support in the preparation of regulatory submissions for investigational and commercial products in line with ICH requirements, regional requirements, and scientific and company policies and procedures.
- Works to develop and acquire required regulatory skills and knowledge, with guidance from immediate manager.
- May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
- Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs.
- Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.
- Seeks assistance from appropriate internal and external resources.
Knowledge and Skills:
- Good organizational skills and ability to work on a number of projects in alignment with timelines.
- Strong verbal and written communication skills and interpersonal skills.
- Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas.
- May act as a resource on a specific topic for other Regulatory personnel within the department.
- Work is performed under the supervision of Regulatory Affairs professionals following detailed instruction with well-defined procedures.
Education and Experience:
- 2+ years of relevant training or industry experience with BS/BA
- 1+ years relevant training or industry experience with advanced degree
- Degree in a scientific field is preferred