Company Pharmacist/Regulatory Officer

2 weeks ago

Quezon City, National Capital Region, Philippines LARGEN MED. INC. Full time ₱2,000,000 - ₱2,500,000 per year

Job Summary:

The Regulatory Pharmacist is responsible for overseeing the regulatory compliance of pharmaceutical products. This includes preparing, reviewing, and submitting documentation to regulatory bodies, ensuring adherence to local and international regulations, and supporting the product lifecycle from development through post-marketing. As part of the Business Development Team, to source and look for new opportunities to grow the company's business through distributors, B2B and B2C channels.

Key Responsibilities:

  • Prepare, compile, and submit regulatory dossiers (e.g., CTD format) for product registrations, renewals, and variations to health authorities.
  • Ensure that all products meet the required regulations and standards (e.g., FDA, EMA, MHRA, TGA, or local authority guidelines).
  • Look for potential growth partnerships that can add to the company's current lineup.
  • Liaise with national and international regulatory agencies to facilitate approvals.
  • Provide regulatory input during product development and clinical trial planning.
  • Monitor changes in regulations and advise internal teams on compliance implications.
  • Review product labeling, promotional materials, and packaging to ensure regulatory compliance.
  • Maintain regulatory files and databases for easy retrieval and reference.
  • Participate in audits and inspections as a regulatory representative.
  • Collaborate with cross-functional teams including R&D, Quality Assurance, Marketing, and Manufacturing.

Qualifications:

  • Bachelor's degree in Pharmacy (BPharm), Doctor of Pharmacy (PharmD), or equivalent.
  • Prior experience in regulatory affairs within the pharmaceutical industry.
  • Knowledge of relevant national and international regulatory guidelines and legislation.
  • Excellent written and verbal communication skills.
  • Strong attention to detail and organizational abilities.

Desirable Skills:

  • Regulatory Affairs Certification (RAC) or similar.
  • Experience with electronic submission tools (e.g., eCTD software).
  • Ability to interpret and apply regulatory intelligence.

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