FDA Regulatory

1 day ago

Manila, National Capital Region, Philippines De Castro Consulting Full time ₱800,000 - ₱1,200,000 per year
Job Summary

We are seeking a highly skilled and detail-oriented FDA Regulatory & CPR Processing Specialist who will lead the effort to obtain, maintain, and manage FDA Certificates of Product Registration (CPR) for our product portfolio. Possession of CPR processing expertise is non-negotiable — this role requires proven experience in registering health / regulated products with the FDA and handling all regulatory activities from submission to renewal, amendment, and audit.

Key Responsibilities

  • Manage the full life cycle of Certificate of Product Registration (CPR) applications: initial registration, renewals, amendments, cancellations, and revalidations.
  • Ensure compliance with FDA regulations, guidelines, and relevant laws for regulated products (food, drugs, cosmetics, medical devices, etc.).
  • Gather required technical, scientific, and regulatory documentation (e.g. test reports, safety data, labeling, certificates of analysis) and ensure completeness before submission.
  • Interface with internal teams (R&D, Quality, Manufacturing, Labeling, Legal) to collect inputs and ensure alignment with regulatory requirements.
  • Prepare and submit regulatory dossiers to the FDA's electronic or paper submission systems, monitor status, respond to observations or queries, and follow up to timely resolution.
  • Maintain regulatory tracking systems, master filing systems, logs (e.g. CPR status, expiration dates, amendment requests), and ensure audit readiness.
  • Monitor changes in regulatory frameworks, FDA updates, and guide product registration strategy accordingly.
  • Support regulatory inspections / audits, prepare responses to audit findings involving CPR issues, and coordinate corrective actions.
  • Provide guidance and training on CPR requirements to internal teams and stakeholders.
  • (Optional) Support health & safety or compliance teams for any regulatory / product safety interface.

Qualifications & Requirements

Mandatory / Non-Negotiable Requirements

  • Demonstrated, hands-on experience in obtaining and managing Certificate(s) of Product Registration (CPR) for regulated products (e.g. food, cosmetics, drugs, medical devices).
  • In-depth knowledge of local FDA / regulatory requirements, guidelines, and processes for product registration.
  • Experience in preparing dossiers, responding to regulatory queries, and handling registration renewals/amendments.

Education & Experience

  • Bachelor's degree (or higher) in Pharmacy, Chemistry, Biology, Regulatory Affairs, Life Sciences, or related field.
  • Minimum 2 years of regulatory affairs / product registration experience.
  • Prior experience interacting with regulatory authorities, preparing submissions, and undergoing regulatory audits.

Skills & Competencies

  • Excellent written and verbal communication skills, especially in regulatory language and scientific contexts.
  • Strong organizational, project management, and prioritization abilities.
  • Meticulous attention to detail, analytical mindset, and problem-solving skills.
  • Ability to work cross-functionally and coordinate with multiple internal stakeholders.
  • High integrity, confidentiality, and commitment to quality.

Other Requirements

  • Must keep abreast of regulatory changes, updates, and trends that affect product registration.
  • Willingness to undergo training, regulatory workshops, and certifications as needed.
  • Ability to travel or liaise with external regulatory bodies if required.

  • Regulatory Affairs Specialist

    2 weeks ago

    Manila, National Capital Region, Philippines OATSIDE Full time ₱900,000 - ₱1,200,000 per year

    Responsibilities:Prepare product specifications and related information upon requestCoordinate with internal and global regulatory team to ensure that the registration dossier meet the requirements of PH FDA and properly manage and resolve the issues.Responsible for product submission in PH FDA e-submission systemDeal with PH FDA on any matters such as...

  • Regulatory/Compliance Officer

    1 week ago

    Manila, National Capital Region, Philippines AvantePH Staffing and Consultancy Inc. Full time ₱900,000 - ₱1,200,000 per year

    We are hiring a Regulatory/Compliance Officer to ensure that the company adheres to government regulations, industry standards, and internal policies. This role will be responsible for developing and monitoring compliance programs, securing and renewing regulatory permits, and coordinating with agencies such as the FDA, IPO, DOLE, BIR, SEC, and LGUs.Key...

  • regulatory affairs officer

    3 days ago

    Manila, National Capital Region, Philippines MRL Cybertec Corp. Full time ₱800,000 - ₱1,200,000 per year

    Graduate of BS PharmacyPreferably with experience in the FDA process.Manage and facilitate all registration activities.Complete forms and requests originating from government agencies.Maintain contact and regulatory authorities and company headquarters.Provide project terms with regulatory input in order to obtain timely regulatory approvals.Deal with...

  • Compliance Officer

    1 week ago

    Manila, National Capital Region, Philippines C'SCOR Full time ₱180,000 - ₱300,000 per year

    Job Summary:The Compliance Officer will be responsible for ensuring that all regulatory requirements are met for baby and oral care products. This includes preparing, submitting, and monitoring documents for government agencies such as the FDA and other relevant authorities. The role ensures that products comply with industry standards, safety guidelines,...

  • Quality Associate

    3 days ago

    Manila, National Capital Region, Philippines BruntWork Full time ₱1,200,000 - ₱2,400,000 per year

    This is a remote position. Schedule: Monday to Friday, 8:00 AM – 5:00 PM AEST Total Weekly Hours: 40 Hours Our client is seeking a Quality Associate to support and lead key elements of the Quality Management System (QMS), ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR where applicable. This role involves oversight and preparation...

  • Corporate Pharmacist-Manila

    3 days ago

    Manila, National Capital Region, Philippines Altamedica Inc. Full time ₱400,000 - ₱800,000 per year

    The Corporate Pharmacist isresponsible for gathering, evaluating, organizing, managing, and collating information in a variety of formats, ensuring compliance with regulations set by the government's regulatory agencies. Maintaining familiarity with company product ranges, planning, undertaking, and regulatory inspections.Must possess at least a Bachelor of...

  • Associate Lawyer

    2 weeks ago

    Manila, National Capital Region, Philippines De Castro Consulting PH Full time ₱600,000 - ₱1,200,000 per year

    Key Responsibilities:Provide legal counsel on corporate, labor, regulatory, and compliance matters.Draft, review, and negotiate contracts, employment agreements, and client documents.Advise clients and internal teams on legal risks, rights, and obligations.Coordinate with government agencies (FDA, SEC, DOLE, BIR) for compliance and licensing.Requirements &...

  • Sales Manager

    1 day ago

    Manila, National Capital Region, Philippines Biocare Lifesciences Inc. Full time ₱1,200,000 - ₱3,600,000 per year

    Company DescriptionBiocare Lifesciences Inc. (BLI) is a Philippine-based pharmaceutical company specializing in the importation, registration, distribution, and ethical marketing of therapeutic products such as Anti-Infective, Pediatric, Nephro, Urology, Pulmo, and Anesthesia. Established in 2011, BLI has quickly built a robust distribution network across...

  • Associate Lawyer

    7 days ago

    Manila, National Capital Region, Philippines De Castro Consulting Full time ₱600,000 - ₱1,200,000 per year

    Position: Associate LawyerLocation: Sampaloc, Manila (Hybrid – 4 days WFH, 1 day On-site)Schedule: Full-time, 9:00 AM – 6:00 PMCompensation: Competitive salary starting at ₱40,000Start Date: ASAPAbout the RoleDe Castro Consulting is seeking a motivated and detail-oriented Associate Lawyer to provide legal expertise in both labor/employment law and...

  • Planning and Procurement Manager for Food Trading Company

    1 week ago

    Manila, National Capital Region, Philippines Turris Phil. Inc. Full time ₱600,000 - ₱1,200,000 per year

    JOB DESCRIPTION:Designing international purchasing strategies for food related itemsBuild relationships and negotiates contracts with international suppliersPreparing cost estimates and managing budgets.Working to improve purchasing systems and processes.Responsible for managing inventory levels and purchase orders to ensure that there is sufficient stock to...