Regulatory Affairs Associate

Highly Competitive Salary
  1. Permanent
  2. Officer /Associate, Publishing & Submissions
  3. United States
San Mateo, USA
Posting date: 28 Jul 2020
RA.CN.30884

Proclinical is currently recruiting for a Regulatory Affairs Associate with a pharmaceutical company located in San Mateo, CA. A successful candidate will have a degree in a scientific field and strong knowledge of regulatory affairs and ICH guidelines.

Job Responsibilities:

  • Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools.
  • 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.
  • 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.

Skills and Requirements:

  • 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, Excel, and Power Point (Project and Visio a plus).
  • Work is performed under the general supervision of more senior Regulatory Affairs professionals and is reviewed for soundness of judgment and overall adequacy.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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