Regulatory Affairs Associate

19 hours ago

Mandaluyong City, National Capital Region, Philippines Brady Pharma Inc. Full time $40,000 - $80,000 per year
Job description

Duties & Responsibilities

  • Assist in preparing all the technical documents required for submission to FDA and other regulatory agencies
  • Responsible for ensuring that all product registrations, licenses, and certificates are valid and submitted to the FDA for renewal prior to the expiration date
  • Update and monitor the registration status and validity date of all regulatory certificates and licenses
  • Establish and maintain document filing system to ensure easy access
  • Participate in inspections of company facilities by FDA and other applicable agencies
  • Submission of Quarterly report for DOH EDPMS
  • Act as a Person in charge, liaison to local regulatory bodies
  • Assist in the preparation of Bidding Documents for submission on Public Bidding for Hospitals
  • Assist in preparing Requirements for Hospital needs.
  • Assist in Sales concerns about product specification and other concerns.
  • Assist the Marketing Department with Promo Permits for FDA compliance
  • Handles Batch Notification for FDA Monitoring
  • Provides support and assistance to Regulatory Affairs Head
  • Perform other regulatory-assigned activities and roles in support of business objectives

Qualifications

  • Must be a Licensed Pharmacist
  • With experience working in Regulatory
  • Must be familiar and knowledgeable in the registration of Drugs, Cosmetics, Medical devices, and Food products
  • Background in handling government account procedures is an advantage
  • Excellent leadership and management skills
  • Honest, patient, and hardworking
  • Willing to work onsite from Monday to Friday

Job Type: Full-time

Work Location: In person

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