regulatory affairs officer

1 day ago

Makati City, National Capital Region, Philippines Mega Lifesciences Limited Inc. Full time

Qualifications:

Bachelor's/ College Degree in Pharmacy (duly registered with the Professional Regulation Commission)

At least 3-5 years of working experience in regulatory affairs and in the pharmaceutical industry

Experience in handling Drug registration is an advantage

Must have good communication skills (both oral and written) and able to work independently or with very minimal supervision.

The Regulatory Affairs Officer shall provide technical and logistic support to legal and registration activities of the Regulatory Affairs Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.

Responsibilities:

Handle registration (review, submission and monitoring) and maintenance of all products under Drug category

Represent the company or act as liaison officer to the local FDA (for assigned products)

Assist the RA Head in complying with the local FDA's regulatory guidelines

Provide regulatory information through preparation of registration updates, maintenance and update of product information, registration dossiers and regulatory files; submission of updated prescribing information and other updates/ variations in technical information to FDA and includes monitoring of implementation; updating of all product monographs for publication in the local compendia

Provide technical support to internal and external customers including, but not limited to:

1.    prompt preparation and compilation of additional regulatory requirements in support of marketing thrusts and directions

2.    provision of updated Certificate of Product Registration to business units for inclusion in drugstores, hospital formularies and bidding purposes

3.    accomplishing regulatory reports for submission to RA Head

4.    Assist in the management of regulatory tools and database

Act as deputy local QPPV (Qualified Person Responsible for Pharmacovigilance)

Perform other job-related duties and responsibilities as determined by RA Head and/or job-related tasks as needed by the company

  • Regulatory Affairs/Quality Officer

    1 day ago

    Quezon City, National Capital Region, Philippines Hexagon Healthcare Corporation Full time

    Job DescriptionOVERVIEW:The Regulatory Affairs Officer / Quality Assurance Officer will handle products registrations in compliance to the regulatory requirements as mandated by specific regulatory agencies. Product lines to register include finished formulations for human consumption, veterinary raw materials and medical supplies. He/She will ensure that...

  • Regulatory Affairs Officer

    1 week ago

    Quezon City, National Capital Region, Philippines Hexagon Group of Companies Full time

    Hexagon Chemical Corporation a well established company and one of the leaders in importation and distribution of Veterinary Pharmaceuticals, Vitamins, Minerals, Amino Acids, Aqua Feed Premix and Other functional Feed Additives is looking for Regulatory Affairs Officer.OVERVIEW:The incumbent is responsible for facilitating the timely application of all...

  • Regulatory Affairs Officer

    1 week ago

    Caloocan City, National Capital Region, Philippines Growrich Manufacturing Inc. Full time

    The Regulatory Affairs Officer is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.Job Type: Full-timePay: Php18, Php21,000.00 per monthBenefits:Additional leaveCompany Christmas giftFree parkingHealth insuranceLife...

  • Regulatory Affairs Officer

    7 days ago

    Quezon City, National Capital Region, Philippines Cosmetix Unlimited Inc Full time

    Key Responsibilities:1. Product Registration and CompliancePrepare, submit, and monitor applications for product registration, renewal, and amendments with the Food and Drug Administration (FDA) and other relevant agencies.Maintain an updated tracker of all regulatory documents, permits, and certificates.Ensure product labels, packaging, and claims are...

  • Regulatory Affairs Specialist

    5 days ago

    Makati City, National Capital Region, Philippines Tag Global Management Corporation Full time

    The Regulatory Affairs Specialist shall provide technical support to legal and registration activities of the RA Department in compliance to the regulatory requirements as mandated by specific regulatory agencies.Qualificationsat least 1 to 2 years of working experience in the related fieldWilling to do field workJob Types: Full-time, PermanentPay: Php22,...

  • Manager Public and Regulatory Affairs

    2 weeks ago

    Makati City, National Capital Region, Philippines OceanaGold Full time

    Company Description OceanaGold is a growing mid-tier gold and copper producer listed on the Toronto Stock Exchange (TSX). With four operating mines—Haile in the USA, Didipio in the Philippines, and Macraes and Waihi in New Zealand—we are committed to safe, responsible mining that generates strong returns and supports sustainable development.Our purpose...

  • Manager Public and Regulatory Affairs

    1 week ago

    Makati City, National Capital Region, Philippines OceanaGold Corporation Full time

    Company DescriptionOceanaGold is a growing mid-tier gold and copper producer listed on the Toronto Stock Exchange (TSX). With four operating mines—Haile in the USA, Didipio in the Philippines, and Macraes and Waihi in New Zealand—we are committed to safe, responsible mining that generates strong returns and supports sustainable development.Our purpose is...

  • Regulatory Affairs Associate

    1 week ago

    Mandaluyong City, National Capital Region, Philippines Brady Pharma Inc. Full time

    Duties & ResponsibilitiesAssist in preparing all the technical documents required for submission to FDA and other regulatory agenciesResponsible for ensuring that all product registrations, licenses, and certificates are valid and submitted to the FDA for renewal prior to the expiration dateUpdate and monitor the registration status and validity date of all...

  • Regulatory Affairs Pharmacist

    2 days ago

    Caloocan City, National Capital Region, Philippines CALA Consumer Products Manufacturing Corp. Full time

    Regulatory Compliance:Ensure company products comply with applicable regulatory standards (FDA, IPO, etc.).Prepare, review, and submit regulatory filings, such as licenses, and certifications.Monitor and keep up to date with changes in regulations, industry standards, and compliance requirements.Act as the primary point of contact with regulatory authorities...

  • Regulatory Affairs Pharmacist

    1 week ago

    Caloocan City, National Capital Region, Philippines Lifestrong Marketing Inc. Full time

    TheRegulatory Affairs Pharmacistensures our company's FDA compliance with all relevant regulations across our Cosmetics products. You will play a key role in developing regulatory strategies, inspection compliance, FDA correspondence and registration of our products. Knowledgeable in FDA rules and policies, strong written and oral communication, organization...