Regulatory Affairs Associate

Los Angeles Metro Area, CA

Posted: 07/24/2020 Job Number: JN -072020-4490

Job Description

Our client, a global life sciences organization, has an immediate need for a Regulatory Affairs Associate to join their team in El Segundo.
  • Responsible for preparing regulatory submissions which require some interactions with other members in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
  • Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity.
  • Responsible for development and acquisition of required regulatory skills and knowledge, with manager support.
  • May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
  • Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department
  • 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.

  • 4+ years of relevant training or industry experience with BS/BA.
  • 3+ years relevant training or industry experience with advanced degree.
  • Degree in a scientific field is preferred.
  • Strong organizational and attention to detail, along with the ability to work on a number of projects with tight timelines.
  • Strong verbal and written communication skills and interpersonal skills.
  • Must have a reasonable understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
  • Proficiency in Microsoft Word and Excel.
  • Experience with Microsoft Power Point, Project and Visio a plus.
  • Act as a resource on limited topics within the department.
  • Work is performed under the general supervision of more senior Regulatory Affairs professionals and is reviewed for soundness of judgment and overall adequacy.

About Vivo

Having been in business since 2006, Vivo is a full-service recruiting and consulting company, specializing in mid to senior level technology resources. Our brand promise is simple: we get people. We get that our clients don t want to waste time and that our candidates and employees thrive when given honest feedback and an opportunity to grow.

Whether you re onsite at our Pleasanton headquarters or working for one of Vivo s clients the best brand names out there our promise to you is unwavering: we will treat you like you are our most important employee.

Do you think you get people get what they really need, and get how to deliver? We re not perfect but we re accountable. We re not in 32 countries, but we are in the heart of it all. So, if you are looking for a flexible, fun and high-energy work environment, along with the opportunity to work with some of the world s technology leaders, we can t wait to talk to you.

Vivo We Get People!
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