Regulatory Affairs Associate

Highly Competitive Salary
  1. Permanent
  2. Other
  3. United States
San Mateo, USA
Posting date: 11 Jan 2021

Proclinical is currently recruiting for a Regulatory Affairs Associate with a pharmaceutical company located in San Mateo, CA.

Job Description:

  • Provides support in the preparation of routine regulatory activities for commercial or investigational products in line with ICH requirements, regional requirements, and scientific and company policies and procedures.
  • Responsible for preparing routine regulatory submissions which require some interactions with others in the Regulatory department for investigational and commercial products, which may include, but are not limited to: safety reports, amendments, supplements, annual reports and aggregate reports.
  • Works to develop and acquire required regulatory skills and knowledge, with guidance from immediate manager.
  • Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.

Skills and Requirements:

  • 1-3 years of relevant training or industry experience with BS/BA.
  • 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 strong understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
  • Proficiency in Microsoft Word and Excel.
  • Experience with Microsoft Power Point and Project a plus.

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.