Regulatory Affairs Associate

2 days ago

Pasay City Central Post Office, Philippines AMBICA INTERNATIONAL CORPORATION Full time ₱180,000 - ₱200,000 per year

A Regulatory Affairs Associate will work collaboratively with all members of Regulatory Department. He/ She acts a responsible person in filing regulatory documents submitted and received from FDA. He/ She will also be the one who will update Regulatory Reports in which he/she will regularly send to all members of Regulatory Department for their reference.

Job Responsibilities

  • Responsible in updating and ensuring the correctness of Regulatory Reports (Reg PCPR and CLIDP Status, GMP List, CLIDP Report, PCPR Report.) and ensures consistency with the Soft and hard copies.
  • Scans and updates the Regulatory Server for FDA submissions and received documents and responsible in ensuring that there will be no missing document.
  • Responsible in ensuring correct filing of all FDA hardcopy receivings to each assigned binder accordingly.
  • Responsible in ensuring correct filing of all application submissions to each assigned binder accordingly.
  • Replies to XD, Sales Coordinator and other department request for copies of Proof of submission for applications.
  • Checking and preparation of original documents, CPRs/CLIDPs, GMP, LTOs for endorsement to the Office of the President.
  • Assist in Assay test submissions
  • Accommodates documents, Cash and Check Requests of Pharmacists then will forward to Vice-President for approval.
  • Prepares Weekly Cash Requests for FDA submissions/payments.
  • Prepares Cash Request for other miscellaneous payments (e.g. Toll Fees, Parking fees etc) then will forward to Accounting Department.
  • Prepares and ensures correctness of liquidation for all FDA payments, Assay, Toll fees, Parking fee and other Regulatory department expenses and corporate credit card.
  • Responsible in forwarding and receiving documents for Notary from Legal Department.
  • Prepares and submits FDA application for Re-issuance.
  • Accommodates all approved request for pull-out of samples from Retention Room
  • Other tasks as assigned by Regulatory Affairs Managers and Head

Job Qualification

  • Preferably B.S. Pharmacy graduate or any 4-year course college graduate.
  • Must have good written and spoken communication skills and ability to multitask as well as work independently and under pressure.
  • Meticulous and keen to details.
  • Proficient in Microsoft Office (MS Word, Excel, PowerPoint, Outlook), PDF (Nitro Pro, Adobe etc.).
  • Able to type fast and accurately.
  • With knowledge or familiarity with pharmaceutical terms/products
  • Exceptionally well organized and strong work ethics.
  • Highly self-motivated and committed to pursuing long term career
  • Fast learner

Job Types: Full-time, Permanent, Fresh graduate

Pay: Php18, Php20,000.00 per month

Benefits:

  • Additional leave
  • Company events
  • Employee discount
  • Health insurance
  • Opportunities for promotion
  • Promotion to permanent employee
  • Transportation service provided

Work Location: In person

  • Regulatory Affairs Associate

    2 days ago

    Caloocan City Central Post Office, Philippines Lifestrong Marketing Full time $104,000 - $130,878 per year

    Job Objective:The Regulatory Affairs Associate is responsible for supporting the regulatory affairs team in ensuring the company's products comply with local regulatory requirements and industry standards. This includes preparing and submitting regulatory documents, interacting with government agencies such as the Food and Drug Administration (FDA)...

  • Regulatory Affairs Associate

    16 hours ago

    Caloocan City Central Post Office, Philippines Lifestrong Marketing Full time $104,000 - $130,878 per year

    Duties and ResponsibilitiesRegulatory Submissions & FilingsSupport in preparing and submitting regulatory documents, including applications for product registrations, licenses, and other approvals required by the FDA Philippines and related agencies.Draft and review dossiers for product registration, renewals, variations, and other filings.Monitor submission...

  • Regulatory Affairs Pharmacist

    2 days ago

    Pasay City Central Post Office, Philippines Medinova Pharmaceutical Inc. Full time ₱250,000 - ₱300,000 per year

    As a regulatory affairs pharmacist, you will be in charge of registering products, evaluating dossiers for product registrations, coordinating and interacting with foreign suppliers, and assessing and reviewing product artworks.QualificationsGraduate of BS Pharmacy and a licensed pharmacist (required)Minimum of 1-2 years of Regulatory experience is preferred...

  • Regulatory Affairs Pharmacist

    2 days ago

    Pasay, National Capital Region, Philippines Dermesse Full time $40,000 - $60,000 per year

    Graduate of BS PharmacyMust be aRegistered PharmacistMust have 1-3 years of experience dealing with FDA and Regulatory AffairsEnsures that all the necessary marketing authorizations are secured and up-to-date prior to operation and/or distribution of products.Responsible for knowing the most current applicable regulations that affect the Cosmetic and Drug...

  • Regulatory Affairs Associate

    2 days 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 Pharmacist

    2 days ago

    Pasay, National Capital Region, Philippines Medinova Pharm. Inc. Full time ₱500,000 - ₱1,000,000 per year

    This is a full-time on-site role. As a Regulatory Affairs Pharmacist, you will be the owner of all processes relating to registering products. Once a product has been identified by our Sales and Business Development team, this is where the Regulatory Affairs Team comes in. Your role is key as it is impossible to offer our products if they have not been duly...

  • Regulatory Affairs Analyst

    2 days ago

    Pasay, National Capital Region, Philippines GB Vision Care Full time ₱500,000 - ₱1,000,000 per year

    About the role GB Vision Care Inc. is seeking a highly skilled Regulatory Affairs Analyst to join our team in Pasay City, Metro Manila. As a Regulatory Affairs Analyst, you will play a crucial role in navigating the complex regulatory landscape within the pharmaceuticals and medical devices industry, ensuring our company's products and operations adhere to...

  • Regulatory Pharmacist

    2 days ago

    Caloocan City Central Post Office, Philippines Lifestrong Marketing Full time $104,000 - $130,878 per year

    The Regulatory Affairs Associate is responsible for supporting the regulatory affairs team in ensuring the company's products comply with local regulatory requirements and industry standards. This includes preparing and submitting regulatory documents, interacting with government agencies such as the Food and Drug Administration (FDA) Philippines, and...

  • Head of Regulatory Affairs

    2 days ago

    Paranaque City, Calabarzon, Philippines Faberco Life Sciences Inc. Full time $90,000 - $120,000 per year

    Direct message the job poster from Faberco Life Sciences IncorporatedHR and Admin Officer at Faberco Life Sciences Inc. PRIMARY OBJECTIVEThe Regulatory Affairs Head is responsible for leading and managing the Regulatory Affairs team in ensuring that all pharmaceutical products comply with applicable regulations in the Philippines. This role involves...

  • QA & Regulatory Affairs Supervisor

    2 days ago

    Caloocan City Central Post Office, Philippines Lifestrong Marketing Full time $104,000 - $130,878 per year

    QUALITY ASSURANCE:Responsible for the final release of products in the absence of Sr. RA/QA Manager.Responsible for ensuring that all third-party suppliers comply with GMP and RGDI Quality StandardsSupervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related policies in...