Regulatory Affairs Officer for FDA Certificate of Product Registration

1 week ago

Makati City, National Capital Region, Philippines Sommelier Selection Inc. Full time ₱315,000 - ₱420,000 per year

Job Summary:

Regulatory affairs officers act as a link between companies and regulatory authorities, ensuring that products are distributed in compliance with appropriate legislation.

Duties and Responsibilities:

  • Ensure that company's products comply with the regulations of the regions where they should be distributed (BFAD, FDA, BAI, NMIS, BIR, etc.)
  • Ensure that quality standards are met and submissions meet strict deadlines.
  • Keep up to date with national and international legislation, guidelines and customer practices.
  • Prepare submissions of license variations and renewals to strict deadlines.
  • Review company practices and provide advice on changes to systems
  • Liaise with regulatory authorities.

Qualifications:

  • At least 1-2 years experience in related field.
  • Must Have experience in filing the FDA Certificate of Product Registration (CPR)
  • Knowledgeable with local distributor compliance process
  • Excellent written and verbal communications skills
  • Good coordination skills and keen attention to details

Job Type: Full-time

Pay: Php25, Php35,000.00 per month

Benefits:

  • Health insurance
  • Life insurance
  • Promotion to permanent employee

Ability to commute/relocate:

  • Makati: Reliably commute or planning to relocate before starting work (Preferred)

Application Question(s):

  • Do you have experience in Filing the CPR / Certificate of Product Registration to FDA?

Experience:

  • FDA CPR : 2 years (Preferred)

Work Location: In person

  • Regulatory Affairs Officer

    7 days ago

    Mandaluyong City, National Capital Region, Philippines Aljeron Medical Enterprises, Inc. Full time ₱360,000 - ₱420,000 per year

    Qualifications:Graduate of Bachelor of Science in Pharmacy, Chemistry, or equivalent.Must have a valid PRC license.With at least 1 year of work experience in MEDICAL DEVICES.Knowledge and skills in Regulatory Documentation, Compliance, and understanding of Regulatory Requirements specific to medical devices.Responsibilities:Ensures that the company complies...

  • Regulatory Affairs Officer

    2 weeks ago

    Mandaluyong City, National Capital Region, Philippines Aljeron Medical Enterprises, Inc. Full time ₱900,000 - ₱1,200,000 per year

    Qualifications:Graduate of Bachelor of Science in Pharmacy, Chemistry, or equivalent.Must have a valid PRC license.With at least 1 year of work experience in the regulatory industry, preferably in Medical Devices.Regulatory experience must be specifically in medical devicesKnowledge and skills in Regulatory Documentation, Compliance, and understanding of...

  • Regulatory Affairs Manager

    5 days ago

    Quezon City, National Capital Region, Philippines Direct Lines Sales Unltd. Inc. Full time ₱960,000 per year

    We are looking for an experienced and detail-oriented Regulatory Affairs (RA) and Quality Assurance (QA) Manager to lead the implementation of company-wide quality systems and ensure full compliance with regulatory requirements.This critical role involves managing audits, maintaining product quality, overseeing documentation, and serving as the primary...

  • Regulatory Affairs Associate

    1 week ago

    Caloocan City, National Capital Region, Philippines Lifestrong Marketing Inc. Full time ₱800,000 - ₱1,200,000 per year

    Job Overview/ Key Responsibilities:Documentation: Prepare and maintain Product Information Files; file and organize FDA-related documents (CPRs, CPNs, LTOs, permits, contracts, audit findings, etc.); monitor license renewals; generate and monitor GS1 barcodes; ensure retention labels and LTO documents are FDA-compliant.Operations: Monitor and track...

  • 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...

  • Regulatory Affairs Pharmacist

    1 week ago

    Quezon City, National Capital Region, Philippines DR. ZEN'S RESEARCH INC. Full time ₱120,000 - ₱180,000 per year

    The Regulatory Affairs Pharmacist is responsible for providing regulatory compliance and requirements in support of the Company's marketing plans, this position is expected to manage all regulatory activities to ensure conformity with FDA standards.Job Types: Full-time, PermanentBenefits:Company Christmas giftCompany eventsEmployee discountGym...

  • Regulatory Pharmacist

    2 weeks ago

    Quezon City, National Capital Region, Philippines Bioessence Group of Companies Full time ₱800,000 - ₱1,200,000 per year

    BenefitsCompetitive compensation packagePerformance-based incentivesPerformance-based salary increaseEmployee discounts and gift certificatesHMO for employee and dependentsAbove standard leave credits (including birthday leave)Employee engagement events and activitiesTerms and conditions applyResponsibilitiesSupervise regulatory processes: FDA registration,...

  • Compliance and Regulatory Affairs Lead

    7 days ago

    Makati City, National Capital Region, Philippines Evian Real Estates Services Full time ₱1,500,000 - ₱2,500,000 per year

    Work Arrangement:Schedule: 6 days a weekWork Setup: On-site / In-personJob Summary:The Compliance and Regulatory Affairs Lead is responsible for overseeing the company's regulatory compliance, business permit renewals, and government coordination activities. This role supervises a compliance support team and acts as the adviser to management on matters...

  • Regulatory Pharmacist

    2 weeks ago

    Quezon City, National Capital Region, Philippines Bioessence Group of Companies (Binondo) Full time ₱384,000 - ₱480,000 per year

    BenefitsCompetitive compensation packagePerformance-based incentivesPerformance-based salary increaseEmployee discounts and gift certificatesHMO for employee and dependentsAbove standard leave credits (including birthday leave)Employee engagement events and activitiesTerms and conditions applyResponsibilitiesSupervise regulatory processes: FDA registration,...

  • Corporate Affairs Assistant

    7 days ago

    Makati City, National Capital Region, Philippines Da Prosperitas Holding Incoporated Full time ₱600,000 - ₱1,200,000 per year

    Work Arrangement:Schedule: 6 days a weekWork Setup: On-site / In-personJob Summary:The Corporate Affairs Assistant is responsible for assisting in the processing and renewal of government registrations, permits, and licenses, including SEC, LGU, and business-related documentation. The role also provides administrative support during DOLE inspections and...