Regulatory Specialist

₱25-40K[Monthly]
On-site - Quezon CityFull-time3-5 Yrs ExpBachelor
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Job Description

PharmaceuticalPlanning

Description

PRODUCT SOURCING FUNCTIONS:

  • Responsible for research, searching and sourcing of products and suppliers in accordance with established quality standard or guidelines.
  • Sourcing of reputable supplier and manufacturer
  • Conducts plant visits and verifies validity of licenses and accreditation.
  • Facilitates pre-launch regulatory documentation and approval.
  • Comes up with a quality control rating scale.
  • Prepares comparative pricing against competitor.
  • • Ascertains supplier’s compliance with the vendor accreditation requirements like CGMP (Certificate of Good Manufacturing Practice) certificate requests, company and product profile and other regulatory documents.


MANAGERIAL FUNCTIONS:

  • Monitors that all products have Drug Assay to ensure quality and complies with standards.
  • Monitors and ensure that product insert and packaging material complies with FDA’s specifications.


ADMINISTRATIVE FUNCTIONS:

  • Maintains updated company license to operate.
  • Checks and monitors inventory of near expiry and products for disposal
  • Facilitates Warehouse Inspection.
  • Finance on profitable cost of goods and product pricing.
  • Maintains and safe keeps manufacturing agreement and distribution contracts of all manufacturers and suppliers as approved by the Legal Department.
  • Develops and updates supplier database.

Requirements

  • 4-year degree in Bachelor of Science in Pharmacy
  • 3 years general experience in Product Research and Development
  • At least 5 years experience in Regulatory
  • At least 3 years supervisory experience in Regulatory
  • Licensed Pharmacist
  • Updated CPD units
  • Extensive research and analysis on product usage and market trends and surveillance of potential products in the pipeline
  • Interpersonal and customer relation skills


Marian Del Espiritu Santo

HR OfficerOxpharm Inc.

Active this week

Working Location

36, 36 Matahimik Street. 36 Matahimik Street, Diliman, Lungsod Quezon, Kalakhang Maynila, Philippines

Benefits

  • Allowances

    Telecommunication Allowance, Medical Reimbursement

  • Employee Recognition and Rewards

    Employee Recognition Program, Incentives

  • Government Mandated Benefits

    13th Month Pay, Employee Loan, Pag-Ibig Fund, Philhealth, SSS/GSIS

  • Insurance Health & Wellness

    Dental Insurance, Health Insurance, Life Insurance

  • Others

    Company Social Events

  • Time Off & Leave

    Bereavement Leave, Birthday Leave, Sick Leave, Solo Parent Leave, Vacation Leave

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Posted on 30 October 2024

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