Associate Regulatory Affairs II Job

ASSOCIATE REGULATORY AFFAIRS II needed for a contract opportunity with Yoh's client located in Thousand Oaks, CA.

The Big Picture - Top Skills You Should Possess:

- Bilingual English/Spanish
- Coordinate and execute the implementation of Regulatory Affairs processes.
- Collate, distribute and review Regulatory information.

What You'll Be Doing:

- To provide administrative support to coordinate and execute the Regulatory submission for products within the company portfolio in compliance with corporate standards, and local regulatory requirements.
- To coordinate and execute the implementation of Regulatory Affairs processes and deliverables.
- To manage and execute the preparation, delivery and electronic archiving of documentation for inclusion in local regulatory submissions.
- To maintain local regulatory, marketing and clinical trial authorizations.
- Executing the preparation of submissions needed to support marketed products.
- Ensuring that documentation is complete, meets internal quality assurance and procedural standards and complies with agency requirements.
- Coordinating and submitting regulatory submission for new and marketed (MAA) medicinal products in accordance with local regulatory agency and internal requirements.
- Assembly and QC of regulatory and published documents.
- Coordinating translation for local Regulatory submission.
- QC support for translated regulatory labels and package component labeling review.
- Archiving and reconciliation of submissions, approvals and other regulatory documentation.
- Providing technical and logistical support to senior members of Regulatory group.

What You Need to Bring to the Table:

- Basic understanding of drug development process.
- Knowledge of key aspects of the regulatory processes.
- Document management and archiving practices.
- Working in a regulated environment Attention to Detail Delivery Focus Communication Skills (verbal/written) Flexibility Team Work Fluent in Spanish.
- Bachelor's degree OR Associate's degree and four (4) years of directly related experience OR High school diploma/GED and six (6) years of directly related experience.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Rob West

Yoh, a DayJ2W: CLINICAL

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