Regulatory Affairs Pharmacist

7 days ago

Quezon City, Philippines Fixus Enterprises Full time

Overview

As a Regulatory Affairs Officer, you will be responsible for ensuring that our medical devices meet all necessary regulatory requirements and standards. Your key responsibilities will include product registration, compliance management, documentation and reporting, pharmacovigilance, communication and collaboration, and staying updated with regulatory changes. You will work closely with cross-functional teams to facilitate regulatory submissions and maintain compliance with FDA regulations.

Product Registration
  • Prepare and submit comprehensive registration dossiers for medical devices.
  • Manage the renewal process for existing product registrations.
  • Monitor the status of registration applications and address any queries from the FDA.
Compliance Management
  • Ensure adherence to all applicable regulatory guidelines regarding medical device labeling, packaging, and advertising.
  • Review and approve marketing materials to ensure accuracy and compliance with regulatory requirements.
  • Conduct regular internal audits to identify potential compliance issues and implement corrective actions.
Documentation and Reporting
  • Maintain accurate and up-to-date regulatory documentation for all products, including product specifications, stability studies, and batch records.
  • Prepare and submit periodic reports to the FDA as required, such as adverse event reports and safety updates.
Pharmacovigilance
  • Monitor and evaluate adverse reactions reported by healthcare professionals and consumers.
  • Report serious adverse events to the FDA according to established procedures.
Communication and Collaboration
  • Collaborate with cross-functional teams including research and development, quality assurance, and marketing to facilitate regulatory submissions and compliance.
  • Liaise with the FDA on regulatory issues and provide necessary information for inspections.
Staying Updated
  • Actively monitor changes in the regulatory landscape and implement necessary updates to company procedures.
  • Attend industry conferences and workshops to stay informed about new regulatory requirements.
Qualifications
  • Bachelor of Science in Pharmacy degree.
  • With or without a license.
  • With or without experience, but experience is a must.
  • Strong understanding of Philippine FDA regulations and guidelines.
  • Excellent written and verbal communication skills.
  • Ability to work under pressure with minimum supervision.
  • Willingness to undergo training.
  • Excellent analytical skills.
#J-18808-Ljbffr

  • Regulatory Affairs Pharmacist

    4 days 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 Pharmacist

    7 days ago

    Quezon City, Philippines Sunfu Solutions, Inc. Full time

    2 weeks ago Be among the first 25 applicants Join us to make an impact in public health in our country! We serve and give solutions to the healthcare sector and we are devoted to bringing quality medical machines to improve lives and strengthen local healthcare capacity building. Job title Associate Regulatory Affairs Specialist (12 months fixed-term...

  • Regulatory Affairs Pharmacist

    2 days ago

    Paranaque City, Calabarzon, Philippines Ambica International Corporation Full time ₱900,000 - ₱1,200,000 per year

    Regulatory Affairs Pharmacistensures that the company complies with applicable FDA and other regulatory related government entities regulations on licenses, technical documents and product registrations. Sr. Regulatory Pharmacist is responsible for preparation, evaluation and submission of Initial application for Drugs, Food, Medical Devices and Cosmetics,...

  • Regulatory Affairs Specialist

    2 weeks ago

    Makati City, National Capital Region, Philippines beBeePharmaceutical Full time ₱600,000 - ₱1,200,000

    Job Overview:Regulatory Pharmacist RoleResponsible for ensuring compliance of documents with FDA guidelines and staying updated with changes in regulatory legislation.A minimum of 1 year of experience in regulatory affairs and good interpersonal and communication skills are required. The ideal candidate will be detail-oriented, analytical, and...

  • QA / Regulatory

    7 days ago

    Cavite City, Philippines Kimiki Solutions Incorporated Full time

    The QA/Regulatory Specialist is responsible for ensuring that products, services, and processes comply with internal and external quality standards, as well as government and industry regulations. This role involves maintaining documentation, conducting audits, managing regulatory submissions, and working closely with cross-functional teams to ensure that...

  • Regulatory Pharmacist

    4 days ago

    Makati City, National Capital Region, Philippines VAVLON Inc. Full time ₱300,000 - ₱500,000 per year

    About the roleVAVLON Inc. is seeking a talented Regulatory Pharmacist to join our team. As a Regulatory Pharmacist, you will play a pivotal role in ensuring the safety, efficacy and quality of pharmaceutical and medical devices. Based in our Makati City office, this full-time position offers the opportunity to contribute to the strategic objectives of our...

  • Regulatory Pharmacist

    6 days ago

    Quezon City, National Capital Region, Philippines SUNFU SOLUTIONS, INC. Full time ₱1,200,000 - ₱2,400,000 per year

    Join us to make an impact in public health in our country We serve and give solutions to the healthcare sector and we are devoted to bringing quality medical machines to improve lives and strengthen local healthcare capacity building.Qualifications:Candidate must be a licensed Pharmacist.Work experience having registered medical devices and supplies or drugs...

  • Regulatory Affairs Specialist

    2 weeks ago

    Iloilo City, Western Visayas, Philippines beBeeRegulatory Full time ₱3,136 - ₱3,744

    Job Title: Regulatory Affairs SpecialistThe Regulatory Affairs Specialist plays a pivotal role in ensuring the organization's policies and procedures align with applicable standards and regulations. This position is responsible for curating and managing organizational-wide policies, ensuring they are up-to-date and compliant.Main Responsibilities:Craft and...

  • Regulatory Affairs Specialist

    2 weeks ago

    Cebu City, Central Visayas, Philippines beBeeRegulatory Full time ₱6,000,000 - ₱8,000,000

    Job Title: Regulatory Affairs ExpertThis position is ideal for a highly motivated and experienced individual with a strong background in regulatory affairs.Evaluate and ensure compliance with applicable laws, regulations, and standards by assessing the impact of regulatory changes on business operations.Develop strategic plans to meet regulatory...

  • Regulatory Affairs Manager

    6 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...