Randstad Regulatory Affairs in Duarte, California
salary:$31 - $33.50 per hour
date posted:Friday, March 9, 2018
Contract position: Our client in Monrovia is looking for a Regulatory Associate 1 to start right away!
Responsibilities for the Regulatory Affairs
Responsible for coordinating and supporting regulatory affairs activities relating to the company's sponsored INDs, investigator-initiated INDs, and Drug Master Files (DMF
Assist with preparation of initial Phase I/II clinical trial IND filings and maintenance of the IND in the setting of an academic research organization. Also will assist in the development and implementation of regulatory strategies for interacting with regulatory agencies and will act as a liaison with the FDA, NIH-OBA, and institutional regulatory committees
Under direction of the Director or designee, establishes and implements standards, approaches, methods, and procedures for the various regulatory affairs activities relating to the development and implementation of novel therapeutics.
Serves as a project lead for portions or all sections of an IND filing, NIH OSP filing, international filing, or DMF filling, as applicable.
Oversees and organizes documentation of user instructions and prepare standard operating procedures (SOPs) for clinical trials conducted under a sponsored IND.
Requirements for the Regulatory Affairs
Requires a Bachelor's degree in a scientific discipline or equivalent. Experience may substitute for minimum education requirements
A minimum of 5 to 7 years related experience with a Bachelors or 3 to 6 years with a Masters, or 2 to 5 years with a PhD, and demonstrated working knowledge of scientific principles.
Up to date familiarity with regulations pertaining to INDs involving CDER, CBER and NIH-OBA activities, including experience as an auditor, quality control coordinator, or compliance officer
- Contractor Benefits available!