Regulatory Affairs Assistant - I in San Mateo, CA at Apex Life Sciences

Date Posted: 9/12/2018

Job Snapshot

Job Description

  • Provides support in the preparation of routine and straight forward regulatory submissions for approved products (e.g. Renewals and supplements to marketing authorizations) in line with regional requirements and scientific and company policies and procedures.
  • May support routine labeling changes and drug listing as required, under guidance from immediate manager.
  • Works to develop and acquire required regulatory skills and knowledge.
  • May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
  • Performs filing and data 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.
  • Strong organization skills and attention to detail, along with the ability to work on a number of projects with tight timelines is required.
  • Strong verbal and written communication skills and interpersonal skills are required.
  • Must be proficient in Microsoft Word and Excel.
  • Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required.
  • Work is performed under the supervision of Regulatory Affairs professionals following detailed instruction with well defined procedures.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.