Regulatory Assistant

UTAK Laboratories
Santa Clarita, CA 91355
United States


Job Description
UTAK Laboratories is currently seeking an experienced individual to fill the position of Regulatory Assistant within the organization. The Regulatory -Marketing Assistant will provide support to marketing, with a focus on regulatory tasks such as product licensing, assisting in regulatory inspections, creating and providing regulatory documentation, guiding projects and project teams, and updating internal operation procedure documentation as needed.
1.Comply with UTAK’s policies, procedures, as well as safety and environmental regulations.
2.Oversee distribution partners to make sure our products are accurately placed in the market
3.Ensure compliance of the company’s products with all applicable regulations.
4.Research and maintain a comprehensive knowledge and understanding of local and international legislation, guidelines and customer practices in all countries where the company is currently or will export products.
5.Collect, collate and evaluate scientific data gathered from research by colleagues.
6.Develop and write clear arguments and explanations for product licensing or regulatory audits.
7.Prepare submissions for license variations and renewal approvals for company products.
8.Update technical documents.
9.Support regulatory inspections.
10.Audit company practices and provide advice about necessary changes to systems and processes.
11.Negotiate with regulatory authorities to obtain marketing authorization.
12.Support the Advertising and Promotions Supervisor by collaborating with vendors to organize UTAK events and industry conferences to meet the Company’s marketing needs.
13.Attend occasional meetings.
14.Promote safety and participate in safety activities:
oAssist in the investigation of all accidents or incidents in work area.
CoImplement safety-related improvements as identified by employees, team leaders, safety professionals and others.

Job Requirements
•Four-Year College Degree or five years of experience in operations or regulatory field, or an equivalent combination of education and experience.
•Basic knowledge of operations procedures and processes required.
•Regulatory adherence experience preferred.
•Experience in business writing or technical writing and professional speaking preferred.
•Possess strong project management skills.
•Fluency in verbal and written English required.
•Work with specialized computer software and resources.
UTAK Laboratories
Christina Plutchak

Santa Clarita CA 91355
United States