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Regulatory Affairs

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


Benefits



  • Contractor Benefits available!


Company Description:

Randstad is a $22.5 billion global provider of HR services and the second largest staffing organization in the world. From temporary staffing to permanent placement to in-house, professionals, search & selection, and HR Solutions, Randstad holds top positions around the world and has approximately 31,100 corporate employees working from its nearly 4,700 branches and in-house locations in 40 countries.


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We are a company built on a deep network of expertise that crosses industries and geographies. We recognize that talent comes in different forms, that every business has its unique challenges and opportunities. And our recruiting experts are skilled at marrying talent and business‚€”identifying the ideal professionals for an organization's culture and its teams, its needs and its goals.




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