Regulatory Affairs Manager

17 hours ago

Mandaluyong City, National Capital Region, Philippines Brady Pharma Inc. Full time $40,000 - $60,000 per year
Job description

Duties and Responsibilities in Regulatory Affairs

  • Evaluate ASEAN documents for registration of pharmaceutical products at FDA.
  • Evaluate and check final submissions of documents for product registration of medical devices, cosmetics, and food supplements.
  • Coordinates with the foreign supplier for the updates in the regulations and other concerns.
  • Review the technical dossier for Foreign GMP clearance in Philippine FDA.
  • Checks and approves packaging material for product registration in compliance to Labeling Requirement for drugs, cosmetics, medical device, and food supplements.
  • Maintain documentation of product dossier for cosmetic audits and other related documents pertains to Regulatory.
  • Prepares and update SOP and Risk Management Plan.
  • Checking and approves application for Batch notification of antibiotic products.
  • Trademark and patent registration in the Intellectual Property Office.
  • Provide assistance in product information and regulatory updates in the Sales & Marketing team.
  • Creates and apply for approval of bar code number/GTIN in the GS1 Philippines.

Duties and Responsibilities in Public Biddings

  • Prepares and checks the eligibility and technical and financial requirements of bid documents in compliance to the Government Procurement policy Board.
  • Check and summarize product inclusions to the account.
  • Attends pre-bid conference or bid opening (if possible) on behalf of the company.
  • Sealing of Bid Documents
  • Seeks price approval and submit quotation to government hospitals
  • Monitors PhilGEPS account for possible product qualifications in different government hospitals and municipals.
  • Prepare and submit documents for supplier accreditation.

Qualifications

  • Must be a Licensed Pharmacist (PRC License must be readily available for the company's LTO)
  • Solid working experience in the Regulatory Affairs
  • Must have completed FDA seminars / with accreditation as Qualified Personnel in Regulatory Affairs (QPIRA) for DRUGS, MEDICAL DEVICES, COSMETICS, and FOOD.
  • Must have knowledge and understanding in the registrations specifically on DRUG products under monitored release and prescription category.
  • Must be familiar with the processing of Foreign Good Manufacturing Practice.
  • With extensive knowledge and background in handling public biddings
  • Must be keen with the latest and updates of FDA regulations
  • Excellent leadership and Management skills
  • Honest, patient, and hardworking
  • Preferably can start as soon as possible

Job Type: Full-time

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Job Type: Full-time

Benefits:

  • Health insurance
  • Life insurance
  • Promotion to permanent employee

Supplemental Pay:

  • 13th month salary
  • Overtime pay

Work Location: In person

  • Regulatory Affairs Assistant

    16 hours ago

    Mandaluyong City, National Capital Region, Philippines RMG Hospital Supply Full time $40,000 - $50,000 per year

    Responsibilities Support Regulatory Officer in processing over-all legal requirements of the company activities such as production registration, renewals, variations, and other regulatory concerns. Assist in liaising with regulatory authorities and ensuring that the quality standards are met, and submissions meet strict deadlines. Provide...

  • Regulatory Affairs Associate

    15 hours ago

    Mandaluyong City, National Capital Region, Philippines Brady Pharma Inc. Full time $40,000 - $80,000 per year

    Job descriptionDuties & 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...

  • Pharmacist (Regulatory Affairs)

    15 hours ago

    Quezon City, National Capital Region, Philippines John Clements Consultants, Inc. Full time $104,000 - $130,878 per year

    Assisting in the preparation and submission of documentation required for FDA drug registration and MAH (Marketing Authorization Holder) license acquisition.Coordinating with regulatory consultants throughout the licensing process to ensure compliance with relevant regulations.Supporting legal and regulatory compliance efforts, including proper documentation...

  • Regulatory Affairs Specialist

    16 hours ago

    Caloocan City, National Capital Region, Philippines Exxel Prime International Trading Inc. Full time $40,000 - $60,000 per year

    Job Title: Regulatory Affairs SpecialistDepartment: Technical ServicesReports To: Technical Services Manager / Technical Services SupervisorLocation: #20 Corner Rose St., Reparo Rd., Barangay 161, Baesa, Caloocan CityWork Setup: On-siteEmployment Type: Probationary (5 months)Job Summary:The Regulatory Affairs Specialist is responsible for ensuring that all...

  • Regulatory Affairs Specialist

    4 days ago

    Makati City, National Capital Region, Philippines beBeeRegulatory Full time ₱800,000 - ₱1,200,000

    Regulatory Affairs SpecialistThis role acts as an end-to-end specialist in regulatory management of multi-regional, regional and national dossiers for assigned clusters/countries/therapeutic areas/products, both initial registration applications and ongoing lifecycle management through to product withdrawal. The successful candidate will be responsible for...

  • Regulatory Affairs Professional

    3 days ago

    Makati City, National Capital Region, Philippines beBeeCompliance Full time ₱900,000 - ₱1,200,000

    Regulatory Compliance SpecialistThis role is responsible for ensuring that all operations meet legal requirements.Key Responsibilities:Oversee customs compliance and regulatory affairs to guarantee seamless operations.Collaborate with cross-functional teams to streamline processes and enhance efficiency.Stay ahead of industry trends and changes in...

  • Manager Public and Regulatory Affairs

    17 hours ago

    Makati City, National Capital Region, Philippines OceanaGold Full time $90,000 - $120,000 per year

    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...

  • Business & Regulatory Affairs Manager (Mandarin)

    16 hours ago

    Makati City, National Capital Region, Philippines OCIC Consulting Int'l. Inc. Full time $40,000 - $80,000 per year

    Business & Regulatory Affairs ManagerFull-Time | On-site | Makati CityWe are seeking a highly driven and detail-oriented Business & Regulatory Affairs Manager to lead our business development efforts, oversee client relations, and ensure full compliance with Philippine licensing and regulatory requirements.If you have strong leadership skills, thrive in a...

  • Regulatory Affairs Associate

    15 hours ago

    Makati City, National Capital Region, Philippines pacific surgical inc. Full time ₱600,000 - ₱1,200,000 per year

    Main FunctionA Regulatory Affairs Associate is responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under government regulations and ensure compliance of the company to Quality Safe Health and Environment policies and...

  • Regulatory Affairs and Quality Assurance Manager

    15 hours ago

    Quezon City, National Capital Region, Philippines QuickStart Solutions Full time $90,000 - $120,000 per year

    Job ResponsibilitiesDevelop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO, FDA, and other applicable standards.Conduct internal and external audits to assess compliance and drive corrective/preventive actions (CAPA).Manage product quality issues, including customer complaints, deviations, and non-conformances.Ensure...