Regulatory Affairs Associate

3 days ago

Makati City, National Capital Region, Philippines pacific surgical inc. Full time ₱120,000 - ₱180,000 per year

Main Function

A 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 procedures.

Duties and Responsibilities:

Regulatory

  • Initial registration and life cycle management of product licenses. ∙ Maintenance of License to Operate as Medical Device Importer/Distributor.
  • Design and implementation of regulatory strategies to meet objectives and timelines set for licensing, registration of products and other related regulatory matters.
  • Conduct regulatory alignment with foreign suppliers for any change in FDA regulation and updates.
  • Acts as the main focal point for Philippines for any regulatory queries from suppliers and provide regulatory support as appropriate
  • Attend to inspector/s during FDA audits.
  • Ensure proper management and safekeeping of records in compliance with FDA regulations.
  • Clearance from other non-FDA regulating bodies (OMB, NTC, etc.)
  • Copy review of promotional materials.
  • Monitors changes in regulatory environment and participates in relevant industry meetings in order to help shape draft regulations in the Philippines.
  • Takes action accordingly to minimize any risk that the company may be subjected to.

Quality Assurance

  • Prepares and updates Standard Operating Procedures (SOP), Work Instructions (WI) and policies on an as-need basis.
  • Product complaints handling and reporting in accordance to supplier SOP.
  • Handles Field Actions in accordance to supplier process.
  • Point person during supplier audits.

Job Requirements:

  • Candidate must possess at least Bachelor's/ College Degree in Pharmacy.
  • Must be a registered Pharmacist.
  • Newly graduate is welcome to apply.

Job Types: Full-time, Permanent

Benefits:

  • Flexible schedule

Work Location: In person

  • Regulatory Affairs Associate

    1 day ago

    Makati City, National Capital Region, Philippines Transmedic Group Full time ₱900,000 - ₱1,200,000 per year

    Job description: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...

  • Regulatory Affairs Associate

    1 day ago

    Makati City, National Capital Region, Philippines pacific surgical inc. Full time ₱1,200,000 - ₱2,400,000 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 Manager

    1 day ago

    Makati City, National Capital Region, Philippines Wellesta Buergli Pharma Inc. Full time ₱1,500,000 - ₱3,000,000 per year

    Job Summary:The Regulatory Affairs Manager is responsible for ensuring that the company's products meet all regulatory requirements and standards in the markets where they are sold. This role involves managing the regulatory approval process, keeping up to date with regulatory changes, and ensuring compliance with all relevant laws and guidelines. The...

  • Regulatory Affairs Specialist

    1 day ago

    Quezon City, National Capital Region, Philippines Pascual Consumer Healthcare Corp. Full time ₱900,000 - ₱1,200,000 per year

    Regulatory Affairs Specialist:Must be a licensed Pharmacist with at least 2 years experience with regulatory affairs within Pharmaceutical industryAt least 1 year exposure to Pharmacovigilance and FDA promo permit submissionKnowledgeable in regulatory requirements for consumer health productsMust be proficient in MS Word, Excel, and OutlookDetail oriented...

  • Regulatory Affairs Associate

    1 day ago

    Mandaluyong City, National Capital Region, Philippines Brady Pharma Inc. Full time $104,000 - $130,878 per year

    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...

  • Pharmacist (Regulatory Affairs)

    3 days ago

    Quezon City, National Capital Region, Philippines John Clements Consultants, Inc. Full time ₱800,000 - ₱1,200,000 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...

  • quality management/regulatory affairs

    3 days ago

    Quezon City, National Capital Region, Philippines DYNA DRUG CORPORATION Full time ₱250,000 - ₱750,000 per year

    Quality Management and Regulatory Affairs SupervisorThe Quality Management and Regulatory Affairs Supervisor serves as the Deputy to the Quality Management Manager and holds primary responsibility for the deliverables and outputs of both the Quality Management and Regulatory Affairs sections. This role ensures the timely and accurate registration of the...

  • Regulatory Affairs Pharmacist

    1 day ago

    Makati City, National Capital Region, Philippines The Raya Clinic Full time ₱60,000 - ₱120,000 per year

    Job Summary:The Regulatory Pharmacist will be responsible for ensuring compliance with Philippine FDA regulations and other applicable laws governing the registration, licensing, distribution, and marketing of pharmaceutical products. The role involves preparing and submitting regulatory dossiers, securing necessary permits, and monitoring regulatory changes...

  • Regulatory Affairs Pharmacist

    1 week ago

    Quezon City, National Capital Region, Philippines New Bilrey Construction & Development Corporation Full time ₱240,000 - ₱360,000 per year

    We are looking for a Licensed Pharmacist with a passion for regulatory work to join our team as a Regulatory Affairs Specialist. In this role, you'll handle permits, licenses, and compliance with FDA and other government agencies—ensuring our operations run smoothly and legally.What You'll Do:Prepare, process, and renew permits, licenses, and...

  • Regulatory Affairs Specialist

    1 day ago

    Quezon City, National Capital Region, Philippines Pascual Consumer Healthcare Corp Full time $104,000 - $130,878 per year

    Regulatory Specialist:· Must be a licensed Pharmacist with at least 2 years experience with regulatory affairs within Pharmaceutical industry· At least 1 year exposure to Pharmacovigilance and FDA promo permit submission· Knowledgeable in regulatory requirements for consumer health products· Must be proficient in MS Word, Excel, and Outlook· Detail...