REGULATORY AFFAIR STAFF (1)(ARKRAY Industry, Inc.)

Job Description:

* Preferably graduate of Pharmacy or any allied course; with at least 6 months working experience; Fresh Graduates can be considered; with working knowledge in ISO 13485 and FDA is an advantage.

Requirements

  • Graduate of Bachelor of Science in Pharmacy or any allied course
  • With at least 6 months or one-year experience in manufacturing set-up
  • Skills Required

  • Knowledgeable in regulatory compliance
  • Duties and Responsibilities

  • Prepares and supports regulatory product submissions or registrations, domestic and internationals.
  • Review documents for compliance with regulatory guidelines.
  • Monitor and setting timelines for FDA license renewal approval and amendment.
  • Responsible for assessing product labeling and claims.
  • Work collaborate with manufacturing to provide newly registered product with accurate information, identify and seek resolution of registration issue for the operational activities.
  • Office Location

      

    Lot 22 Phase 1A, First Philippine Industrial Park, Sta. Anastacia, Sto. Tomas, Batangas 4234