regulatory affairs associate

2 months ago


Manila, National Capital Region, Philippines Unilab Inc. Full time

It is the spirit of Bayanihan that drives us to continue our legacy of excellence and commitment to care. As an organization, we achieve our successes through good, honest, and persevering hard work - TOGETHER. It is in this way in which our company was built; we progressed as the country's leading Pharmaceutical company, not by sheer luck, but by pure perseverance, integrity, and brotherhood. Grow with us, and be a part of the Bayanihan spirit.

Role Overview

  • Coordinates registration requirements with enablers
  • Evaluates thoroughly the registration documents and requirements for completeness, accuracy and quality that is compliant with the requirements of the Food and Drug Administration
  • Prepares the registration documents and requirements in conformance with the checklist of requirements of the Food and Drug Administration
  • Files, monitors and closely follows up applications with the Food and Drug Administration
  • Facilitates request for early evaluation and processing of registration applications
  • Provides inputs in the formulation of strategies for a faster and more efficient registration process
  • Represents the department in New Products Meetings or any registration-related meetings
  • Disseminates critical registration information to areas concerned within the company
  • Monitors and tracks company product registrations and licenses and ensuring compliance with basic company and Food and Drug Administration requirements and timelines
  • Files amendments/variations with the Food and Drug Administration
  • Ensures timely access to updated regulations and other relevant information
  • Provides interpretation of regulatory policies and requirements and identifies linkages and relationships among them
  • Maintains and update of registration dossiers
  • Prepares the monthly operations report on assigned product category

    Required Qualifications
    • Graduate of BS Pharmacy
    • Must be a Licensed Pharmacist
    • With 3-6 years regulatory experience
    • With negotiation skills
    • With technical and regulatory knowledge in pharmaceutical, food, medical devices, and cosmetics, PDEA, DDB
    • Can work with minimal supervision
    • Has good interpersonal skills
    • Preferably with driver's license

      We are committed to providing our employees with the best possible experience. As a LEARNING ORGANIZATION, we are eager to support your development and create the most fitting career path for you. As DESIGNERS AND DRIVERS OF INNOVATION, we are keen to provide you with opportunities to positively transform processes that will intensify business growth. As a NURTURING FAMILY, we are passionate about conducting programs that can promote your wellness, and help you be the best that you can be. As BELIEVERS OF OUR PURPOSE, we are and we will always remain earnest in giving meaningful tasks that will keep you delighted and fulfilled - at work and beyond.


  • Manila, National Capital Region, Philippines Ajanta Pharma Philippines Inc Full time

    Job Title : Regulatory Affairs AssociateReports to: Regulatory Affairs ManagerAjanta Pharma Philippines,Inc.Regulatory Affairs Associate Job Description Responsibilitiesensure that a company's products comply with the regulations of Philippines Law including the FDA Philippines regulationskeep up to date with national and Southeast Asian legislation,...


  • Manila, National Capital Region, Philippines Aljeron Medical Enterprises, Inc. Full time

    Role DescriptionThis is a full-time on-site role for a Regulatory Affairs Specialist at Aljeron Medical. The Regulatory Affairs Specialist will be responsible for handling regulatory documentation, ensuring regulatory compliance, and understanding and meeting regulatory requirements. He/She/They will be responsible for spearheading all regulatory activities...


  • Manila, National Capital Region, Philippines Cobden & Carter International Full time

    One of the biggest FMCG companies in the Philippines is looking for a Regulatory Affairs Manager who will lead in ensuring that products, processes, and marketing strategies adhere to local, regional, and global food regulations. The role aims to drive compliance in the dynamic regulatory landscape. Responsibilities: Strengthen the Regulatory Affairs' role...

  • Regulatory Affairs

    2 weeks ago


    Manila, National Capital Region, Philippines Manpower Philippines Full time

    An academic degree on health sciences, life sciences, regulatory affairs (eg. Physician, Pharmacist, Veterinarian or Scientific background, as applicable based on countries' jurisdiction.Minimum of 2 years' experience from the pharmaceutical or healthcare sectorExperience in regulatory affairs, excellent writing and presentation skillsStrong knowledge of...


  • Manila, National Capital Region, Philippines Q2 HR Solutions Inc. Full time

    Location: San Juan CityWork Arrangement: Monday to Friday (on-site)The Regulatory Affairs Officer will be responsible for ensuring that our company's products comply with local and international regulatory requirements. This role involves working closely with the Food and Drug Administration (FDA) in the Philippines, managing documentation, submissions, and...


  • Manila, National Capital Region, Philippines ANDAMAN MEDICAL PHILIPPINES CORPORATION Full time

    We Are Looking for Applicants Residing in Metro Manila.Andaman Medical is a young and fast-growing Medical Device Regulatory Affairs & Market Access consultancy. We specialize in the registration, authorized representation, importation, master distribution, quality assurance and compliance of medical device and in-vitro diagnostics (IVD) in Southeast Asia....


  • Manila, National Capital Region, Philippines A Brown Company, Inc. Full time

    About the roleReporting to the AVP, Compliance Officer, this full-time Regulatory Affairs Staff role is responsible for ensuring A Brown Company, Inc. operations in Quezon City, Metro Manila adhere to all relevant laws, regulations and industry standards. This is a key position that plays a vital part in maintaining the company's strong reputation and...


  • Manila, National Capital Region, Philippines SUN PHARMA PHILIPPINES, INC. Full time

    SUN PHARMA PHILIPPINES, INC. is a subsidiary company of Sun Pharmaceutical Industries Ltd. SUN PHARMA is the 1st largest pharmaceutical company in India and the world 4th largest specialty generics pharmaceutical company committed in providing international standards of quality. With 43 state-of-the-art manufacturing facilities spanning 5 continents located...


  • Manila, National Capital Region, Philippines Business Trends Philippines Full time

    About the roleJoin Business Trends Philippines as an Imports Planning and Regulatory Affairs Compliance Executive based in Makati City, Metro Manila. In this full-time role, you will be responsible for ensuring compliance with all relevant regulations and laws related to the importation of pharmaceutical and medical devices products.The Imports Planning &...


  • Manila, National Capital Region, Philippines Ambica International Corporation Full time

    Job DescriptionThe Sale and Regulatory Affairs communicates with the regulatory department for the needed documents from suppliers, such as PIC/s GMP Certificate, Apostilled WHO-GMP Certificate (if non-PIC/s country), GMP Evidence Dossier, Product Stability Studies Report, Certificate of Pharmaceutical Product (COPP), Certificate of Analysis (COA) of...


  • Manila, National Capital Region, Philippines Private Advertiser Full time

    Ensures company products comply with the regulations and policies of FDA/Regulatory Authorities.Prepares submissions of different regulatory documents such as license variations and renewals to strict deadlines.Monitors and sets timelines for license variations and renewal approvals.Develops and prepares regulatory documents for new product licenses and...

  • Regulatory Affairs

    7 days ago


    Manila, National Capital Region, Philippines Partners' ChoiceMed Inc. Full time

    Key Responsibilities:Represents the company in dealing with government agencies,particularly with the Food and Drug Administration and the Department of Health.Communicates / requests product registration dossier from product principals.Collates, evaluates and prepares registration dossiers of medicaldevices for submissions of initial, renewal, amendment and...


  • Manila, National Capital Region, Philippines MRL Cybertec Corp. Full time

    Graduate of BS Pharmacy other related course.Preferably 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...

  • Regulatory Pharmacist

    3 months ago


    Manila, National Capital Region, Philippines AMB HK Enterprises Inc. Full time

    Job Qualifications:Candidate must possess at least Bachelor's/College Degree in PharmacyLicensed PharmacistAt least 1 year experience in regulatory affairs.Knowledge in ASEAN Medical Devices DirectiveExperience in medical device registration is an advantage. Duties and Responsibilities: Review of the medical devices dossier and documents based on ASEAN...


  • Manila, National Capital Region, Philippines Metro Retail Stores Group, Inc. Full time

    JOB SUMMARY:Maintain regulatory compliance of the company and liase with different government agencies like FDA ( CFRR, CCRR and CDRRHR), DA ( NMIS, BPI, BFAR) and DTI- Bureau of Product Standards).Candidate must possess at least a Bachelor's/College Degree of PharmacyAt least 2-3 year(s) of working experience in Regulatory dealing with government agencies...

  • Regulatory Pharmacist

    2 hours ago


    Manila, National Capital Region, Philippines Cosmetique Asia Corporation Full time

    Company BackgroundCosmetique Asia Corporation, is a prominent player in the cosmetic and fragrance industry. The company's popular brands include Silka Papaya Soap, Juicy Cologne, Biogenic Alcohol, and Bambini Baby Cologne. With a focus on product innovation and meeting consumer needs, Cosmetique Asia continues to expand its portfolio.Position Overview:We...


  • Manila, National Capital Region, Philippines Alpha-Pharma Healthcare (PH) Inc. Full time

    Alpha-Pharma Healthcare is presently recruiting regulatory affairs executives to expand the company's drug registration efforts throughout South East Asia. The ideal candidate will be a pharmacist ) or chemistry ) graduate with 5-8 years of experience in QA/RA. Experience with eCTD compliance and publishing is preferred. We expect you to be well versed with...


  • Manila, National Capital Region, Philippines Nezus Phils. Corporation Full time

    JOB DESCRIPTIONThe Regulatory and Importation Associate shall be in charge of handling and managing product registration activities of the company to ensure compliance to all government regulatory agencies. The position is also responsible in handling product importations and in collaborating the process with the different suppliers of the company.DUTIES &...


  • Manila, National Capital Region, Philippines Philippine Medical Systems Inc. Full time

    Key Job Responsibilities:Executes liaison work with government agencies such as the Bureau of Food and Drugs and Department of Health; Acts as the representative of the company in government regulatory requirements;Processes and monitors BFAD and DOH license for renewal and accreditation and filling-out forms/payments of renewal and request of product...


  • Manila, National Capital Region, Philippines Private Advertiser Full time

    Prepare and review registration documents for a specific productsProcessing of FDA registration for medical devicesSend emails and coordinating with international supplier