Job Category: Clinical Affairs
Job Number: 11668264
Akraya is looking for a Regulatory Affairs Associate for one of our clients. If the job description below is a fit, please apply directly or call Sherwin Gardner at 408-338-6119.If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.
Primary Skills: Document Filing, Tracking, Indexing, Retrieving. Regulatory & Training skills and ICH requirements
Duration: 12 Months
Contract Type: W2 only
- 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
Please apply directly with your updated resume or call Sherwin Gardner at 408-338-6119
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.