regulatory assistant

2 days ago

Angeles City, Central Luzon, Philippines Mary Roche' Marketing Full time ₱250,000 - ₱500,000 per year

We are seeking a passionate and experienced Regulatory Assistant to join our growing team.As a Regulatory Assistant, you will be responsible for preparing, reviewing, and submitting regulatory documents to ensure compliance with FDA, DOH, and other health authorities. You will collaborate with cross-functional teams to support product registrations, renewals, biddings, small volume purchases, government purchases and documentation and variations, while staying updated on evolving regulations and policies.

RESPONSIBILITIES AND DUTIES

  • Prepare and submit product registration dossiers, renewals, amendments, and  variations in compliance with regulatory authority requirements (e.g., FDA, DOH)
  • Liaise with government regulatory agencies to ensure timely approval and registration of products
  • Maintain regulatory files and documentation in accordance with company policies and regulatory requirements
  • Monitor, Prepare, File and coordinate with Admin Assistant on all government Bids, tenders, Small Volume Procurements, Emergency Purchases and other government related documentation processes
  • Monitor changes in relevant laws and regulations and assess their impact on company operations and product portfolios
  • Provide regulatory input during product development, packaging, and labeling reviews
  • Support internal audits and inspections related to regulatory compliance
  • Ensure that all marketed products remain compliant with applicable laws and regulations throughout their lifecycle

QUALIFICATIONS AND REQUIREMENTS

  • Bachelor's degree in Pharmacy (With PRC license)
  • Minimum 1 year of experience in a regulatory affairs role within the pharmaceutical, medical device, or healthcare industry
  • Knowledge of local (e.g., Philippines FDA, DOH) and international regulatory requirements
  • Strong attention to detail and organizational skills
  • Excellent written and verbal communication skills
  • Ability to manage multiple projects and deadlines
  • Proficiency in MS Office applications (Word, Excel, PowerPoint)
  • Regulatory certification is a plus (e.g., RAC)

About us

Mary Roche' Marketing is one of the fast growing Pharmaceutical and Medical Device company known for its innovative and results-driven campaigns. We are a fast-paced, dynamic, and collaborative work environment that values creativity, teamwork, and a commitment to excellence. Our mission is to help our clients achieve their business goals through high quality and innovative products that transcends well beyond healthcare.

If you're excited about the prospect of joining our team, we encourage you to apply now

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